Cone Beam Computed Tomographic evaluation of dentin bridge formation using Mineral Trioxide Aggregate with Melatonin and Freeze Dried Amniotic Membrane for Direct Pulp Capping in permanent Molars A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Dentin bridge formation in the compared groups evaluated with the help of intra oral periapical radiograph (IOPAR) and Cone Beam Computed Tomography (CBCT)
Study Overview
Brief Summary
The vitality of the pulp is essential for the protection of the tooth structure and the maintenance of proper physiological function. Following pulp exposure and Direct Pulp Capping, early changes include hemorrhage and moderate inflammation, resolved during the first week [1] In turn, this might also provide a conducive environment for the formation of reparative dentin if the bacterial irritation and inflammatory reaction are successfully mitigated. The release of calcium ions from the DPC biomaterials stimulates the precipitation of calcium carbonate in the wound area and thereby contributes to the initiation of mineralization. After placing Mineral Trioxide Aggregate (MTA) material over the exposed pulp, MTA activates the progenitor cells (fibroblast) migration from the central pulp to the exposure area. This helps to promote their proliferation and differentiation into odontoblast-like cells without inducing apoptosis in the pulp cells [2]. MTA induces a time-dependent environment that is proinflammatory and promotes wound regeneration through upregulation of cytokines [3]. Cytokine upregulation is responsible for the induction of biomineralization by the production of collagen fibrils or apatite-like clusters at the dentin-MTA interface. MTA releases calcium ions which exert antibacterial effects and promote mineralization beneath the pulp exposure area and has the potential to maintain the vitality of the pulp [4]. Previosly melatonin given orally in animal studies have shown to have similar effects such as MTA. Human Amniotic Membrane has also shown healing of inflammed pulp when placed direcly on exposed pulp.[5,6,7]
References:
1) ElSebaai A, Wahba AH, Grawish ME, Elkalla IH. Calcium hydroxide paste, mineral trioxide aggregate, and formocresol as direct pulp capping agents in primary molars: A randomized controlled clinical trial. Pediatr Dent 2022;44(6):411-5.E14-E15.
2) Bui AH, Pham KV. Evaluation of reparative dentine bridge formation after direct pulp capping with biodentine. Int Soc Prevent Communit Dent 2021;11:77-82.
3) Reyes-Carmona JF, Santos AS, Figueiredo CP, Baggio CH, Felippe MC, Felippe WT, et al. Host–mineral trioxide aggregate inflammatory molecular signaling and biomineralization ability. J Endod 2010;36:1347–53.
4) Kunert M, Lukomska-Szymanska M. Bio-inductive materials in direct and indirect pulp capping—a review article. Mater 2020;13:1204.
5) Johri S, Verma P, Bains R,Human amniotic membrane as therapeutic agent in pulpotomy of permanent molars. BMJ Case Rep 2021;14:e243414.
6) Amniotic Membrane versus Formocresol as Pulpotomy Agents in Human Primary Molars: An in vivo Study Pesquisa Brasileira em Odontopediatria e Clinica Integrada 2017, 17(1):e3794
7) Julia Guerrero-Gironés, Antonia Alcaina-Lorente, Clara Ortiz-Ruiz, Eduardo Ortiz-Ruiz. Melatonin as an Agent for Direct Pulp-Capping Treatment. Int. J. Environ. Res. Public Health 2020, 17, 1043.
8) Keskin Ş, Şengül F, Şirin B. Evaluating the cytotoxic effect of melatonin and oxyresveratrol on dental pulp stem cells. Eurasian J Med (2023);55(1):32-36.
9) Rafiqul islam, Md refat readul islam, tora tanaka. Direct pul capping procedures - evidence and practice. Jpn Dent Sci Rev, 2023 Dec, 59:48-61.
10) Cobanoglu N, Alptekin T, Kitagawa H, Blatz MB, Imazato S, Ozer F. Evaluation of human pulp tissue response following direct pulp capping with a self-etching adhesive system containing MDPB. Dent Mater J 2021;40:689–96.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 30.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with class 1 deep carious lesion in mandibular first and second molar Teeth with vital pulp, mature apex.
Exclusion Criteria
- •Patients with habit of tobacco chewing and smoking Pregnant and lactating mothers Diabetic patients Teeth with immature apex, periapical pathosis Teeth with irreversible pulpitis.
Outcomes
Primary Outcomes
Dentin bridge formation in the compared groups evaluated with the help of intra oral periapical radiograph (IOPAR) and Cone Beam Computed Tomography (CBCT)
Time Frame: Baseline response before starting the procedure, immediately after treatment, 3 months, 6months, 9months and 12 months after treatment
Secondary Outcomes
- Resolution of signs and symptoms clinically and radiographically(Resolution of pain assessed with help of pain scale)
Investigators
DrPraveena Sharma
Subbaiah Institute of Dental Sciences
