Comparative evaluation of PRF and PRF-based nano biomaterial as pulpotomy agent in young permanent teeth in children- Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Clinical criteria: The tooth will be evaluated for the presence/ absence of pain, swelling, tenderness on percussion, pathological mobility, and purulent discharge at 3, 6, 9, and 12 months.
Study Overview
Brief Summary
This study focuses on evaluating the effectiveness of platelet-rich fibrin (PRF) and PRF-based nano biomaterials as pulpotomy agents in vital young permanent first molars in children aged 7-9 years. The randomized controlled trial aims to assess both clinical and radiographic outcomes of these treatments over intervals of 3, 6, 9, and 12 months. Key clinical criteria include the presence of pain, swelling, tenderness on percussion, pathological mobility, and purulent discharge, while radiographic criteria include the assessment of periapical radiolucency, furcal involvement, and root resorption. Additionally, the study monitors the duration required for apical closure.
Participants will be selected based on specific inclusion criteria, such as having caries in permanent mandibular first molars requiring vital pulp therapy, deep dentin caries with pulp exposure, and mild to moderate responses to stimuli. Teeth must be in Nolla’s stage 7 or 8 of root development. Exclusion criteria include teeth with irreversible pulpitis, mobility, abscesses, fistulas, significant radiolucency, and internal or external root resorption. Children with systemic problems, congenital abnormalities, or special needs are also excluded.
The study involves preparing PRF using Choukroun’s technique and agglomerating it with nanomaterials to ensure uniform distribution. The procedure includes local anesthesia, rubber-dam isolation, cavity preparation, and caries removal, followed by the application of the assigned pulpotomy agents. The PRF and nanomaterial mixture will be applied in a 3:1 ratio, covering the chamber floor and followed by Glass Ionomer Cement (GIC) and composite restoration. Radiographs will be taken using a standardized technique to ensure consistency.
The research aims to determine if the addition of nano chitosan and nano-hydroxyapatite to PRF enhances the healing process and accelerates the clinical outcomes, specifically the apical closure. By standardizing the treatment duration for apical closure in teeth at Nolla’s stage 7 and 8, the study could potentially extend the applicability of these biomaterials to teeth at various stages of root development. This could provide a more effective and faster treatment option for children with cariously exposed pulp in young permanent teeth, leveraging the regenerative properties of PRF and the biocompatibility of nano chitosan and nano-hydroxyapatite.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 7.00 Year(s) to 9.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Enrolment of children with caries in Permanent mandibular first molars requiring vital pulp therapy, exhibiting deep dentin caries with pulp exposure, and mild to moderate responses to chemical and thermal stimuli.
- •Radiographically detected with caries penetration involving the full dentin thickness with pulp involvement and the teeth in Nolla’s stage 7,8 root development.
Exclusion Criteria
- •Encompass teeth with irreversible pulpitis, mobility, abscess, fistula, or radiolucency in furcation or periapical regions, and internal or external root resorption.
- •Children with systemic problems, congenital abnormalities, or special needs are excluded.
Outcomes
Primary Outcomes
Clinical criteria: The tooth will be evaluated for the presence/ absence of pain, swelling, tenderness on percussion, pathological mobility, and purulent discharge at 3, 6, 9, and 12 months.
Time Frame: Clinical criteria: The tooth will be evaluated for the presence/ absence of pain, swelling, tenderness on percussion, pathological mobility, and purulent discharge at 3, 6, 9, and 12 months.
Secondary Outcomes
- Radiographic criteria: The tooth will be evaluated for the presence /absence of radiographic periapical radiolucency pathologically, furcal involvement, and internal or external resorption.(Apical closure: The teeth will be checked for apical closure and the duration taken for the apex to close.)
Investigators
DrDaya Srinivasan
Chettinad Dental College and Research Institute
