Evaluating the effectiveness of four different types of sealants in preventing dental caries in permanent teeth among children aged 6-14 years residing in an orphanage of Mysuru city.
- Conditions
- Children with permanent molars and premolars with deep pits and fissures.
- Registration Number
- CTRI/2021/08/036022
- Lead Sponsor
- JSS Dental College and Hospital JSS Academy of Higher Education and Research
- Brief Summary
Rationale and backgroundinformation**Introduction**: Dental caries is the mostcommon oral disease in children and adolescents1. Literatureindicates that more than 50% of carious lesions occurring among school childreninvolve occlusal surface which is attributed to the presence of deep pits andfissures with their irregularities and invaginations2. Thetopography of fissures makes mechanical removal of plaque bacteria from toothsurface difficult. Fluorides in different forms are most effective inpreventing caries on smooth and proximal surfaces. However, they are lesseffective on occlusal surfaces. Pits and fissures are eight times morevulnerable to become carious in comparison with smooth surfaces.3 Currentconcept of minimally invasive dentistry emphasizes the need to focus onprevention rather than treatment of an established disease. The sealing with anocclusal barrier isolates the occlusal surface from the surrounding environmentpreventing the onset of caries.
**Statement of the problem/Hypothesis:** Pit and fissure sealants are an ideal way ofpreventing dental caries on occlusal pits and fissures. Although, four different types of sealants namely resin based sealants,glass Ionomer based sealants, resin modified glass Ionomer sealants andpolyacid modified resin sealants are widely used for preventing occlusal cariesamong susceptibles,4-12 current evidence on comparativeeffectiveness of different types of sealants is very weak according to asystematic review by American Dental Association and American Academy ofpediatric dentistry.13 This highlights the need for clinical trialsthat compare the effectiveness of different types of sealants in preventingdental caries. Hence, this study is undertaken to compare retention andeffectiveness of four different types of sealants (resin based, glass ionomerbased, resin modified glass ionomer and polyacid modified resin sealants) inpreventing dental caries on occlusal surfaces of permanent first and secondmolars and premolars among 6-14 years old children selected from orphanages of Mysurucity.
**Purpose and significance of Research:** The newly erupted molars and premolars are highly susceptible to caries, andthis is the time at which sealants are highly advisable especially among lowerclass children who are at high risk for dental caries. This research providesan opportunity to offer primary preventive service (sealant application) forchildren from selected orphanages of Mysuru city who are otherwise are deprivedof such services while facilitating us to evaluate and compare sealantretention between four different types of sealants.
**Aim&Objectives**
**Aim:** To compare the retention and effectiveness of four different types ofsealants (resin based, glass ionomer based, resin modified glass ionomer andpolyacid modified resin-based sealants) in preventing dental caries on occlusalsurfaces of permanent first and second molars and premolars among 6-14 yearsold children selected from orphanages in Mysuru city.
**Objectives:**
1. Toidentify and undertake pit and fissure sealant application in first and secondpermanent molars and premolars using four different types of sealants (resin-basedsealants, glass ionomer-based sealants, resin modified glass ionomer sealantsand polyacid based resin sealants) among 6 -14 years old school children selected from orphanages in Mysuru city.
2. Toevaluate and compare sealant retention and its effectiveness in preventingdental caries increments between four different types of sealants during the 18months follow up period.
3. To provide strategic recommendationon the sealant ideally suited for application in field settings such as orphanageswhere sophisticated dental equipment may not be available.
MethodologyData collection procedure**Type& duration of study:**This will be a split mouth double blind randomizedcontrol trial conducted over a period of 24 months.
**Study setting & source of data:** The study will be conducted among 6-14 years old children selected from orphanages in Mysuru city.
**Ethical clearance and informed consent:** Study will be conductedin accordance with the guidelines of Declaration of Helsinki for biomedicalresearch involving human subjects (World Medical Association Declaration ofHelsinki, 2001). Ethicalclearance will be obtained from Institutional Ethics Committee (IEC). Data will be collected aftertaking consent from the wardens/caretakers of these children. An assent fromchildren will also be taken before recruiting the children into the study.Permission will be obtained from the headmaster of the school.
**Sample size and its estimation including samplingprocedure:** Sample size was estimated usingnMaster software (Department of Biostatistics, Christian Medical College,Vellore) for Repeated measures Analysis of Variance (With intra classcorrelation coefficient - ICC) between four different time intervals. Thesample size was estimated to be 29 teeth per group at an assumed within groupvariance of 0.2, between group variance of 0.5, intra class correlationcoefficient of 0.8, effect size of 0.6, 80% power and 5% level of significance.However, the sample size was rounded off to 35 teeth per group to compensatefor an anticipated 20% loss to follow up.
Anorphanage housing students in the age range of 6-14 years will be identified.All the children in this orphanage will be screened by a trained investigatorto identify children in the age range of 6-14 years who require sealant applicationin at least four teeth (first and second permanent molars and premolars) intheir mouth. Children from other orphanages will be considered if requirednumber of eligible children are not available in the selected orphanage.
**Sampleselection criteria:**
**Inclusioncriteria:**
1. Children with permanent molars andpremolars with deep pits and fissures
2. Children with at least four permanentmolars and premolars requiring sealant applications
3. Children who are willing toparticipate in the study with consent from their wardens/caretakers
**Exclusion criteria:**
1. Children with gross oral defectswhich interfere with mastication resulting in unilateral mastication
2. Children presenting with generalizedattrition of permanent teeth indicating bruxism
3. Uncooperative children not willing tooffer assent
4. Children not available for follow upexaminations
**Withdrawal criteria:** Children experiencing any unanticipated side effectsfollowing intervention.Suchchildren will be offered required care by the investigator.
**Trial registration:**The trial will be registered with clinical trial registry of India. The trialwill be carried out in accordance with the guidelines of declaration ofHelsinki.
**Baselinedata collection:** A structured close endedquestionnaire will be used to document demographic details, oral hygienepractices, dietary habits, medical and dental history. A sterile mouth mirror,explorer and CPITN probe will be used for clinical oral examination ofchildren. Examination will be performed on a portable dental chair under adequateillumination within the premises of orphanage.
**Randomizationand intervention:** The selected childrenwill be provided sealant application using four different types of sealants bya single trained investigator. Computer generated random allocation sequencewill be used for assigning the type of sealant to be applied for four differentteeth within the same mouth. The random allocation will be undertaken by thecoordinator of the trial.
A child requiring four sealantapplications in his/her mouth will be given four different types of sealants(resin-based sealant, glass ionomer-based sealant, resin modified glass ionomersealant and polyacid based resin sealant) in four different teeth according tothe manufacturer’s instructions.
The following sealants which arecommercially available will be applied
1. Resin based- 3m Espe Clinpro Sealant
2. GIC based- Gc Fuji 7 Sealant
3. Resin modified GIC- HY Bond resiglass SHOU
4. Polyacid modified resin- Dyract seal
**Blinding:**Details ofrandomization will be concealed from the investigator involved in follow upexamination of children. Data sheets compiled during the study period atdifferent time intervals will be kept confidential till the completion of studyto ensure blinding.
**Follow up examinations:** Follow up examinationswill be undertaken at intervals of six months for 18 months followingintervention by one calibrated investigator who is not involved inintervention.
Sealant retention and caries status in thesealed teeth following intervention will be assessed using modified Simonsen’scriteria.14
**Score 0:** No loss of sealant and no evidenceof caries
**Score 1:** Partial loss of sealant and noevidence of caries
**Score 2:** Partial loss of sealant and evidenceof caries
**Score 3:** Complete loss of sealant and noevidence of caries
**Score 4:** Complete loss of sealant andevidence of caries
**Re-application of sealants:**Children with partially or completely lost sealants who require reapplicationof sealants will be offered the same type of sealant that was offered at thetime of intervention by the same investigator. Number of such reapplicationsundertaken over a period of 18 months for different teeth in each child will bedocumented in their data collection sheets.
**Dataanalysis procedure**
**Statistical methods:** Dataanalysis will be done using SPSS 24.0. Comparison of proportion of sealantsretained, sealant failures and new caries increments between the four sealantgroups will be done at each time interval using Pearson’s Chi square test.Comparison of proportion of sealants retained, sealant failures and cariesincrement in each group between baseline and subsequent follow up examinationswill be done using Friedman’s test. Mean number of teeth requiringreapplication of sealants between the four different sealant groups at eachtime interval will be compared using one way Analysis of variance and Tukey’spost hoc test. Effect size indicating the magnitude of difference will becomputed. Statistical significance will be fixed at 0.05.
**Expectedoutcome and social relevance/Implications:** This randomized control trial will add to theexisting body of evidence on the comparative effectiveness of four differenttypes of sealants which in fact is week at present, while facilitating us toevaluate and identify the ideal sealant type that could be recommended in thesekinds of field settings. Underprivileged children from these orphanages will beoffered preventive procedures which they would not have receivedotherwise.
References
1. Wright JT, Crall JJ, Fontana M, Gillette EJ, NovýBB, Dhar V, et al. Evidence-based clinical practice guideline for the use ofpit-and-fissure sealants. J Am Dent Assoc. 2016 Aug; 147(8):672-82.
2. Prabhakar A, Dahake PT, et al. Fluoride: is it worthto be added in pit and fissure sealants? Int J Clin Pediatr Dent 2012;5:1–5.DOI: 10.5005
3. Ganss C, Klimek J, Gleim A. One-year clinicalevaluation of the retention and quality of two fluoride releasing sealants.Clin Oral Investig 1999;3(4):188-193.
4. Waggoner WF, Siegal M. Pit and fissure sealantapplication: Updating the technique. J Am Dent Assoc 1996;127:351‑61.
5. Reem Naaman, Azza A. El-Housseiny , and NajlaaAlamoudi. The Use of Pit and Fissure Sealants—A Literature Review. Dent. J.2017, 5, 34; doi:10.3390/dj5040034
6. Wendt LK, Koch G, Birkhed D. On the retention andeffectiveness of fissure sealant in permanent molars after 15 to 20 years: Acohort study. Community Dent Oral Epidemiol 2001;29(4):302-307.
7. de Luca-Fraga LR, Pimenta LA. Clinical evaluation ofglass ionomer/resin-based hybrid materials used as pit and fissure sealants.Quintessence Int 2001;32(6):463-468
8. Hassan AM, Mohammed SG. Effectiveness of Seven Typesof Sealants: Retention after One Year. Int J Clin Pediatr Dent2019;12(2):96–100.
9. Priscilla Santana Pinto Gonçalves, Tatiana YurikoKobayashi, Thais Marchini de Oliveira, Heitor Marques Honório, Daniela Rios,Salete Moura Bonifácio da Silva. Pit and Fissure Sealants with DifferentMaterials: Resin Based x Glass Ionomer Cement – Results after Six Months.Brazilian Research in Pediatric Dentistry and Integrated Clinic 2016,16(1):15-23.
10. Reddy VR,Chowdhary N, Mukunda KS, Kiran NK, Kavyarani BS, Pradeep MC. Retention ofresin-based filled and unfilled pit and fissure sealants: A comparativeclinical study. Contemp Clin Dent 2015;6:S18-23.
11. Kumaran P.Clinical Evaluation of the Retention of Different Pit and Fissure Sealants: A1-Year Study. Int J Clin Pediatr Dent 2013;6(3):183-187.
12. HaricharanPB, Barad N, Patil CR, Voruganti S, Mudrakola DP, Turagam N. Dawn of a New AgeFissure Sealant? A Study Evaluating the Clinical Performance of Embrace WetBondand ART Sealants: Results from a Randomized Controlled Clinical Trial. Eur JDent. 2019 Oct; 13(4): 503–509.
13. Wright JT,Crall JJ, Fontana M, Gillette EJ, Nový BB, Dhar V, Donly K, Hewlett ER,Quinonez RB, Chaffin J, Crespin M. Evidence-based clinical practice guidelinefor the use of pit-and-fissure sealants: a report of the American DentalAssociation and the American Academy of Pediatric Dentistry. The Journal of theAmerican Dental Association. 2016 Aug 1;147(8):672-82.
14. SimonsenRJ. Pit and fissure sealant: Review of the literature. Pediatric Dent2002;24(5):393-314.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 35
- Children with permanent molars and premolars with deep pits and fissures 2.
- Children with at least four permanent molars and premolars requiring sealant applications 3.
- Children who are willing to participate in the study with consent from their wardens/caretakers.
- Children with gross oral defects which interfere with mastication resulting in unilateral mastication 2.
- Children presenting with generalized attrition of permanent teeth indicating bruxism 3.
- Uncooperative children not willing to offer assent 4.
- Children not available for follow up examinations.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sealant retention and caries status in the sealed teeth following intervention will be assessed using modified Simonsen’s criteria. 6 months, 12 months and 18 months following intervention.
- Secondary Outcome Measures
Name Time Method Prevention of Dental Caries Every six months following intervention for 18 months.
Trial Locations
- Locations (1)
JSS Dental College and Hospital
🇮🇳Mysore, KARNATAKA, India
JSS Dental College and Hospital🇮🇳Mysore, KARNATAKA, IndiaDr Mirunalini SPrincipal investigator9500561019mirunaasundar63@gmail.com