<img src="../assets/images/corporate.jpg" width=740 height=100 border=0>
 
Home Page
About DENTSPLY Asia
Product
Calendar of Events
Clinical Forum
Contact Us
DENTSPLY International
New!
New!

 


Seal&Protect

New clinical data and a new packaging

The sealing of pits and fissures is an established method for caries prevention. The sealing of cervical surfaces was introduced only recently, Seal&Protect being the first product offering mechanical and antibacterial protection. From the clinical investigation of this cervical sealant by A. Baysan and E. L. Lynch at St. Bartholomew's and the Royal London School of Medicine and Dentistry data on the 19-month recall have become available.

It was previously shown that wear of Seal&Protect is about half of that of cervical dentine. After 19 months, mean wear (137) was less than the mean sealing thickness (169).

Cariostatic properties became evident as sealing cervical surfaces with Seal&Protect resulted in a reduction of the proportion of isolated mutans streptococci species. This may be associated with the smoothness of the resin surface, enhanced by the release of fluoride and triclosan contained in the sealing and released into the overlaying pellicle and plaque.

Sensitivity had been drastically reduced after 3 months and was still significantly lower at 19 months than at baseline.

The investigators concluded that Seal&Protect may be considered to provide multiple clinical therapeutic benefits including the prevention of cervical wear, control of root caries as well as the reduction of dentinal hypersensitivity.


Treatment of cervical sensitivity with a root sealant

 AYLIN BAYSAN, BDS, MSC PHD & E LYNCH, MA, BDENTSC, PHD FDS RCS

 

Abstract: Purpose: To assess a novel root sealant for cervical sensitivity.

 

Materials and Methods: Clinical assessments, impressions and modified USPHS criteria (n= 24) were carried out at baseline, 3, 6 and 19 months. Plaque samplings were performed at baseline and after 3 and 19 months.

 

Results: At 19 months, 20 patients completed the clinical trial. There was a significant reduction for the sensitivity scores. The log10 of total colony-forming units (cfu + 1) from overlying plaque significantly reduced. The percentage of mutans streptococci reduced after 3 months (P< 0.01) and yeasts also reduced after 19 months (P< 0.01). The mean overall wear (¡Ó SD) (mm) on the sealant was 78.8 ¡Ó 21.3 at 3 months; 95.4 ¡Ó 7.3 after 6 months and 136.5 ¡Ó 9.8 after 19 months. In conclusion, this sealant was capable of reducing sensitivity. Further wear on the cervical surface was prevented as the mean sealant thickness was 65.3 ¡Ó 3.3 after 19 months. (Am J Dent 2003;16:000-000).


Clinical significance:
The sealant was capable of reducing sensitivity for a period of 19 months and there was a significant reduction of some representative caries associated micro-organisms in the overlying plaque.


Introduction


Dentin sensitivity is one of the most painful and least predictably treated clinical conditions. It has been established that dentin hypersensitivity affects 1 in 6 people.1

The clinical challenge to treat hypersensitivity may be to occlude patent tubules to reduce any stimulus-evoked fluid flow and intradental nerve excitability so that the nerves do not respond to the stimulus-evoked fluid movements. However, current methods to manage cervical sensitivity are unreliable. A wide range of topical agents have been used to treat dentin hypersensitivity but none of them is completely effective in the management of dentin sensitivity.2 Restorative filling materials applied to dentin appear to reduce sensitivity for as long as they remain on the surface. When the material is lost, cervical sensitivity tends to return.3 This may be associated with a cohesive failure of the restoration and adhesive interface within the tooth, thereby exposing the dentin tubules to the oral environment again. There is a need for more durable materials that can provide permanent and effective surface barrier.

The aim of this study was to assess a new protective root sealant for the treatment of cervical sensitivity by the employment of sensitivity scores, modified United States Public Health Service (USPHS) criteria, microbiological and novel three-dimensional analyses.


Materials and Methods

Study population
This 19-month study was carried out with patients recruited from those attending the Department of Adult Oral Health at St. Bartholomew's and the Royal London School of Medicine and Dentistry. Ethical approval was obtained from the Local District Ethics Committee (P/97/282) prior to the commencement of the study. A total of 24 patients with at least one cervical sensitive dentin were selected and signed consent forms were obtained. The mean ¡Ó standard error (S.E.) age of the subjects at baseline was 60.17 ¡Ó 2.48 years with a minimum age of 24 and maximum of 76 years.

The protective root sealant
This root sealant (Seal & Protecta) contained a mixture of dimethacrylate resins in acetone as a solvent, with triclosan and fluoride.

Study design
Baseline -
Patient questionnaires, plaque samplings and standardized clinical assessments using an air sensitivity score were carried out. The air sensitivity scores were determined using an application of air (25 PSI) from a three in one syringe lasting 1-second and directed perpendicular to the cervical surface at a distance of 0.5 mm. The patients were asked to rate the perception of sensitivity experienced during this air stimulation by providing a mark on a scale from 0 to 9. A score of 0 was defined as no pain, 1-4 as mild sensitivity and 5-9 as strong sensitivity (which was reported spontaneously by the patients during eating, drinking and/or brushing their teeth).

 

The cervical surfaces were then cleaned using a slow-speed handpiece with a rubber cup and prophylaxis paste. An impression using light-bodied addition-cured silicone (Extrudeb) impression material was then taken from the cervical dentin surfaces as described by Jovanovski et al.4 The root sealants were applied and agitated over the surface of the cavity for 30 seconds and each increment was cured with the same light curing equipmenta for a period of 20 seconds according to the manufacturer's recommendations. Five increments of the root sealant were applied on each cervical surface. Each sealant was then polished using a slow speed handpiece with a rubber cup and prophylaxis paste. Second impressions were taken to measure the thickness of the sealant by the employment of 3-D digitization. Following the application of root sealant, color, marginal adaptation, anatomic form, surface roughness and marginal discoloration were assessed by modified USPHS criteria.5 All patients were given oral hygiene instructions and dietary advice. Clinical assessments regarding sensitivity scores and modified USPHS criteria were carried out after 3, 6 and 19 months.


Three-dimensional data analys
es -
Impressions were taken from the sealants at baseline and after 3, 6 and 19 months as described by Jovanovski and Lynch.6 The volume and area of applied sealants were measured using computer models of the replica surfaces reconstructed from data acquired by a Co-ordinate Measuring Machine (Merlin Mk II 750c) fitted with a laser probe (Renishaw OP2d). Three-dimensional coordinates were acquired from the surface of each replica with a spacing of 100 µm in the xy plane to obtain a data set consisting of approximately 10,000 data points per. Sequential data sets from each subject at baseline, 3, 6 and 19 months were superposed (brought into a common reference frame) for the comparison replica.4,6,7

 

Microbiological analyses - At baseline, plaque samples were taken from the untreated sensitive dentin surfaces using a sterile dental excavator. After 3 and 19 months, plaque samples were also taken from the surface of each sealant. If the sealants were lost, plaque samples were carried out from sensitive cervical surfaces of the teeth. Each sample was then immediately placed in 1 ml of fastidious anaerobe broth (FAB LABMe) and forwarded to the microbiological laboratory within 30 minutes for microbiological investigation. The sample processing methods described by Beighton et al8 were performed.


Statistical analyses
Sensitivity scores -
At baseline and at time points of 3, 6 and 19 months, sensitivity scores for each test tooth were recorded. Wilcoxon Matched-Pairs Signed-Ranks test was employed to compare the sensitivity scores at baseline and at time points of 3, 6 and 19 months with the threshold of significance chosen at 0.05.  


Three-dimensional data analysis
-
The wear of the sealant was summarized into a single numerical value by measuring the volume loss over a square region of standard size (µm2) located around the mid-line (or alternatively, around the area of maximum loss) at the time points of 3, 6 and 19 months. Since the region size was standard, the mean depth of the wear over such a region was proportional to the lost volume. The means (¡Ó S.E.) of the sealant thickness and wear on the sealant were then recorded.  

 

Microbiological analyses - Microbiological counts from baseline and at time points of 3 and 19 months were transformed as log10 (colony forming units + 1) prior to statistical analyses in order to normalize their distributions. Mean ¡Ó S.E. was calculated for total number of microorganisms and specific species which were isolated from each sample site. Statistical analyses of the data were obtained using Wilcoxon Matched-Pairs Signed-Ranks tests with the threshold of significance at 0.05.


Results

Twenty-four subjects were enrolled into the study. All subjects received the assigned treatment at baseline. After 19 months, 20 subjects finished the study. There were no observed adverse events. This study assessed whether the root sealant was capable of reducing sensitivity and remaining on the cervical surface. The numbers of representative caries associated microorganisms in the overlying plaque were also determined.

When the cervical surface was sealed, further wear on the cervical surface was prevented. Sealing dentin tubules with this root sealant reduced sensitivity. This novel sealant was associated with a reduction in the numbers of some representative caries associated microorganisms in the overlying plaque after 3 months.

 

Sensitivity scores - There was a significant reduction for the sensitivity scores (mean ¡Ó S.E.) 0.36 ¡Ó 0.12 at 3 months follow-up (P< 0.0001); 0.94 ¡Ó 0.40 after 6 months and 2.08 ¡Ó 0.78 after 19 months (P< 0.001); compared with baseline 6.95 ¡Ó 0.27 (Fig. 1).

Figure 1. Sensitivity scores at baseline and at time points of 3, 6 and 19 months.


Modified USPHS criteria - All sealants were clinically assessed for color match, marginal discoloration, anatomic form, marginal adaptation, surface roughness and secondary caries after 3, 6 and 19 months. These results were as follows:

 

3-month follow-up - There were - no discolorations, 8 anatomic form failures, 7 marginal fractures and 3 sealants with surface roughness. 


6
-month follow-up -
No discolorations, 9 anatomic form failures, 8 marginal fractures, 4 sealants with surface roughness and 4 lost sealants were recorded. 

 

19-month follow-up - No discolorations, 12 anatomic form failures, 12 marginal fractures, 8 sealants with surface roughness and 5 lost sealants were observed.  

 

Three-dimensional data analyses - The mean (µm) (¡Ó SE) sealant thickness was 169.2 ¡Ó 3.5 at baseline (Fig. 2). Mean (µm) (¡Ó SE) wear on the root sealant was 78.8 ¡Ó 5.1 at the 3 month follow-up, 95.4 ¡Ó 7.1 after 6 months and 136.5 ¡Ó 8.9 at the 19 month follow-up (Fig. 3). After 19 months, the mean wear was less than the mean sealant thickness.

Fig. 2. Color-coded subtraction image of ¡¥before sealant application¡¦ and ¡¥after sealant application¡¦ surfaces.



Fig. 3.
Sealant wear at 3, 6 and 19 months - Subtraction maps.


Microbiological analyses - The effects of the sealant on the representative caries associated microorganisms were evaluated before application of sealant and at time points of 3 and 19 months as shown in Table 1.

Discussion

In this study, sensitivity scores were dramatically reduced after 3 months compared to baseline and were still significantly less than the baseline scores after 6 and 19 months. These significant differences were likely to have been related to the sealing of this protective material on the patent dentin tubules. The resistance to wear during 19 months was less than anticipated. It can be speculated that this may have been related to the hydrophilic resin and additional added constituents in the sealant. Sensitivity scores slightly increased after 19 months when compared to those at the 3 and 6 month recalls. However, this increase in sensitivity scores in the test teeth (n = 5) was entirely associated with lost sealants as measured clinically on the same teeth. It should be noted that patients with intact sealants on the cervical surfaces presented no sign of sensitivity during the study.

 

It was surprising that the reduction of some of the micro-organisms persisted for 3 months. This may be associated with several factors including smoothness of the resin surface, release of cytotoxic constituents from the sealant, the different contact angle and/or surface energy of the sealant compared to the previous tooth surface. Siegrist et al.,9 showed a similar effect on the reduction of plaque deposition on different dental materials. These authors showed that smooth surfaces such as gold harbored sparse deposits, while the rougher materials (e.g., amalgam) were covered by more plaque. Sealing of the rough exposed dentin surfaces with this smooth sealant may have also been associated with less plaque accumulation. In addition, the operative procedure itself might have had some impact on these results.

 

It is widely known that S. mutans is the predominant micro-organism in the initiation of root caries. Beighton et al.,8 found that root caries which were situated within 1 mm of the gingival margin had an increased frequency of isolation of mutans streptococci, lactobacilli, and yeasts. In this study, the numbers of isolated mutans streptococci, yeasts and lactobacilli showed significant reductions after 3 and 19 months and not surprisingly, there was no initiation of carious lesions on these cervical surfaces during the 19-month period. However, the numbers of Gram-positive pleomorphic rods (GPPR) increased after 3 and 19 months. It should be noted that GPPR predominate in all lesions and their numbers fail to vary between lesions with different textures. Therefore their numbers seem to provide an unreliable indication of the severity of lesions.

 

The root sealant provided a long-term seal of the patent dentin tubules on some of the teeth as three-dimensional analyses showed that some sealants were still present after 19 months. Furthermore, the mean wear was less than the mean sealant thickness at the end of the study.

 

Five increments of the root sealant were applied to the cervical dentin surfaces at baseline. However, the application of the sealant is in two increments according to the manufacturers. The reason for the 5-increment application was to assure that this novel sealant could be detected both by the employment of the three dimensional superposition technique and clinical assessments. In addition, the average thickness of each increment was approximately 35 µm at baseline and the average wear on the sealant was approximately 28 µm at each month especially in the early months.

 

The most widely accepted evaluation technique is to use the USPHS criteria to assess gross changes with restorative materials.10 However, there is no evaluation of wear of the restoration surface as a whole. The large amount of subjectivity involved in scoring preclude comparisons between different clinical studies using this scale. Objective quantitative results can be obtained by analyses of three-dimensional coordinate data. It is possible to determine minimal changes in the cervical surfaces quantitatively and visually in terms of computer graphics with this technique.

 

Different clinical trials managing dentine sensitivity are difficult to compare as these trials differ in their duration and methodology. A major problem arises from the variations in sensitivity assessments. Some studies report changes in the perceived levels of discomfort evoked by a "standard" stimulus such as a 1-second blast of air. Some studies provide only one measure of sensitivity, while others include several different and independent measures of sensitivity. In this study, a standard method of air stimulus was used.

 

There is a need for the treatment of dentin sensitivity. Therefore, this paper assessed a novel root sealant, which contains several constituents such as fluoride, triclosan and resins. A double blind clinical study has been planned to investigate the effect of the constituents on reducing numbers of total micro-organisms. In addition, a control group without any sealant especially in the same subject on the opposite quadrant could also be assessed.

 

In conclusion, there was a significant reduction in sensitivity scores compared to baseline after 19 months. The protective sealant was found to be capable of covering the cervical surface to prevent further wear. In addition, there was a significant reduction of some representative caries associated microorganisms in the overlying plaque. This new root sealant may then be considered to provide multiple clinical therapeutic benefits including reducing and preventing dentin hypersensitivity.

 

a. Dentsply, Konstanz, Germany.
b. Kerr, Romulus, WI, USA.
c. Merlin Mk II 750c
,Japand. Renishaw OP2
d.
Japan
e. Bury, Lancs, UK.

 

Acknowledgements: The authors wish to thank Dr. Jovanovski and Mrs. Zou for their support with the metrological analyses and Prof Beigthon and Dr. Brailsfrod for carrying out the microbiological analyses. The investigation was supported by Dentsply, European Division, Germany.

 

Dr. Baysan is Clinical Lecturer, Department of Restorative Dentistry, at the University of Birmingham, School Dentistry, Birmingham, UK. Prof. Lynch is Professor of Restorative Dentistry and Gerodontology, Queen's University Belfast, Belfast, Northern Ireland.


 

References

1. Orchardson R. Hypersensitive teeth: Clinical features and assessing treatment. Bulletin Kanagawa Dent Col 1995;23:49-54.
2. Orchardson R, Gillam DG. The efficacy of potassium salts as agents for treating dentine hypersensitivity. J Orofacial Pain 2000;14:9-19.
3. Orchardson R, Gangarosa LP, Holland GR, Pashley DH, Trowbridge HO, Ashley FP, Kleinberg I, Zappa U. Dentine hypersensitivity-into the 21st century. Arch Oral
Biol
1994;39:113S-119S.
4. Jovanovski V, Tay WM, Zou L, Anderson IJ, Cox MG, Forbes AB, Allred H, Morganstein SI, Lynch E. Objective assessment of three-dimensional structures in clinical dentistry using methods of coordinate metrology. Nanobiology 1996;
4:55
-61.
5. Council on Dental Materials, Instruments and Equipment. Revised American Dental Association acceptance program Guidelines for dentin and enamel adhesive materials. 1994.

6. Jovanovski V, Lynch E. Analysis of the morphology of oral structures from 3-D co-ordinate data. In: Monographs in Oral Science, Vol. 1
7: Assessment of Oral Health (Faller R V). S Karger AG,
Basel, 2000, 73-129.7. Yeganeh S, Lynch E, Jovanovski V, Zou L. Quantification of root surface plaque using a new 3-D laser scanning method .J Clin Periodontol 1999;26:692-697.
8. Beighton D, Lynch E, Heath MR. A microbiological study of primary root caries lesions with different treatment needs. J Dent Res 1993;73:623-629.
9. Siegrist BE, Brecx MC, Gusberti FA, Joss A, Lang NP. In vivo early human dental plaque formation on different supporting substances. A scanning electron microscopic and bacteriological study. Clin Oral Implants Res 1991;
2:38-46.
10. Ryge G, Jendresen MD, Glantz PO, Mjor I. Standardization of clinical investigators for studies of restorative materials. Swedish Dent J 1981;5:235-239.



Fig. 4.
Sealant wear at time points of 3, 6 and 19 months - Midline profile.



Table 1. Isolated microorganisms in Log10 (cfu + 1) (Mean ¡Ó SE) and percentages (Mean ¡Ó SE) at baseline and after 3 and 19 months (Percentages in parenthesis)

Microorganisms
Baseline
Sealant (3 months)
Sealant (19 months)
Total microorganisms 5.94 ¡Ó 0.20 3.77 ¡Ó 0.32* 4.76 ¡Ó 0.72
Mutans streptococci 5.04 ¡Ó 0.24  (1.17 ¡Ó 0.75) 0.76 ¡Ó 0.28 *
(0.31 ¡Ó 0.15*)
1.04 ¡Ó 0.44*
(1.54 ¡Ó 1.47)
Yeasts 0.58 ¡Ó 0.25  (0.02 ¡Ó 0.01) 0.22 ¡Ó 0.16 *
(0.13 ¡Ó 0.10)
0.07 ¡Ó 0.07*
(0.003 ¡Ó 0.003*)
GPPR 1.33 ¡Ó 0.61  (13.12 ¡Ó 6.89) 0.62 ¡Ó 0.27 *
(15.61 ¡Ó 8.04)
4.52 ¡Ó