Evaluation of retention rate and caries preventive effects of 2% Chitosan based pit and fissure sealants in permanent 1st molars - A Randomised Trial

Not yet recruiting

Conditions: children with deep pits and fissures

Registration Number: CTRI/2023/06/054321

Lead Sponsor: NAINA KUMAR

Brief Summary: Dental caries is a multifactorial local disease resulting in destruction of the hard tissues of the teeth by metabolites produced by oral microorganisms.

Dental sealants were introduced in the 1960s to help prevent dental caries, mainly in the pits and fissures of occlusal tooth surfaces.

Occlusal surfaces of newly erupted permanent molars are considered more prone to carious process owing to the findings that plaque accumulation was higher and thicker in partly erupted teeth because of incomplete occlusal interdigitation, limited mechanical oral function and requirement of more intense plaque control in comparison to fully erupted teeth.

It has been suggested that sealant placement should be done within four years of eruption based upon the premise that tooth surfaces are likely to remain caries free if it has survived intact for more than four years following eruption.

Strong antimicrobial properties are employed by most commonly incorporated agents i.e., Fluoride and Chlorhexidine in resin materials initially which may get depleted over a period of time and they may also cause alteration of mechanical properties decreasing the bonding strength of resin materials significantly.

Chitosan a naturally occurring biopolymer, has gained importance since the past few years owing to its natural organic nature, antioxidant , non-toxic, mucoadhesiveness, bacteriostatic and bactericidal properties. It alters the cellular permeability via interaction between cationic polysaccharide and anionic membranal components.

Various in-vitro studies have been conducted estimating the properties of chitosan based pit and fissure sealant in which 2% chitosan showed better antibacterial efficacy compared to chitosan free control group. However, the efficacy of same in oral environment is yet to be evaluated. Therefore, this study aims to assess the efficacy of 2% chitosan based pit and fissure sealant clinically.

In an in-vitro study chitosan/fluoride microparticles prepared by spray drying showed potential utility as vehicles to enhance fluoride retention and promote its controlled fluoride delivery in the oral cavity by increasing fluoride uptake from oral care products to provide increased protection against caries.

Therefore, chitosan in resin based pit and fissure sealant may improve caries preventive effect of sealant by increasing fluoride uptake that is present in sealant and causing sustained delivery of same in oral cavity over a longer period of time.

Hence, the study aims to clinically assess the retention rate and caries preventive effects of modified 2% (chitosan based) and unmodified resin pit and fissure sealant on newly erupted permanent 1st molars at the intervals of 3 and 6 months.

Study is a split-mouth study in which mandibular and maxillary permanent 1st molars on one side will receive unmodified pit and fissure sealant while mandibular and maxillary permanent 1st molars of other side will receive modified pit and fissure sealant in a same individual

GROUP I: 64 caries free permanent 1st molars (2 in each patient) of 32 children fulfilling inclusion criteria will be selected for application of Clinpro pit and fissure sealant (control group)

GROUP II: 64 caries free permanent 1st molars (2 in each patient) of 32 children fulfilling inclusion criteria will be selected for application of 2% Chitosan based Clinpro pit and fissure sealant (study group)

Finally, the retention rate and caries preventive effects of both will be evaluated at 3 and 6 months after placement.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 32

Inclusion Criteria

I.Healthy children aged between 6 and 10 years.
II.Children who are at moderate to high risk of caries lesion development.
III.Children with presence of early non-cavitated lesions on their permanent 1st molars.
Cooperative children with medical, fitness or intellectual impairment.

Exclusion Criteria

I.Uncooperative children II.
Children with molar incisor hypoplasia, dental fluorosis, or suspected deep caries lesions III.
Children enrolled in any fluoridation program IV.
Children with bruxism or parafunctional habits.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate retention rate of modified pit and fissure sealant at the interval of 3 and 6 months after placement	3 and 6 months

Secondary Outcome Measures

Name	Time	Method
To evaluate caries preventive effect of modified pit and fissure sealant at the interval of 3 and 6 months after placement	3 and 6 months

Trial Locations

Locations (1): A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES
🇮🇳
Kannada, KARNATAKA, India
A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES
🇮🇳Kannada, KARNATAKA, India
NAINA KUMAR
Principal investigator
9119655559
nainakumarmi@gmail.com