Comparative evaluation of N-acetyl cysteine and Mineral trioxide aggregate (MTA) as pulpotomy medicaments in primary molars: A 12-month follow-up randomized clinical trial
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Sanket Vijay Parmalkar
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- N acetyl cysteine will show better or equal results as compared to MTA when used as a pulpotomy agent
Overview
Brief Summary
Pulpotomy is widely used for treatment of primary tooth to maintain its integrity until normal exfoliation. An ideal pulpotomy material should have appropriate sealing ability, bio-inductivity, biocompatibility, and have the ability to eliminate bacteria and preserve healthy radicular pulp and promote its healing. However, none of the available and recommended medicaments for pulp therapy present all these properties.Although Formocresol (FC) has long been considered to be the gold standard, researchers are questioning its use in pulpotomy because of possible mutagenic and toxic effects. Different materials such as calcium hydroxide, ferric sulfate, and glutaraldehyde have been suggested as an alternative for FC.Numerous medicaments with various protocols that retain radicular pulp vitality from time to time since the success of pulpotomy relies on medicament used. Owing to intricacies of earlier medicaments, the thrive for better drug made clinicians eye toward regenerative materials in the recent past. Mineral trioxide aggregate (MTA) is one such regenerative material recognized as the reference material for conservative pulp vitality treatments in primary teeth, with high pulpotomy success rates (90%–100%) in clinical, radiographic, and histopathologic studies.
N-acetylcysteine (NAC) is a membrane-permeable aminothiol compound with diverse functions. NAC is shown to be the precursor of GSH with a significant antioxidant effect.NAC has also been regarded as an anti-inflammatory compound. Therefore, NAC is shown to have a number of different functions depending on the nature of the cells and their stage of maturation. However, it seems one of the primary functions of NAC is inhibition of cell death. At present it is unclear how NAC protects the cells from cell death. However, previous work has attributed the protective effect of NAC in HEMA- and TEGDMA-mediated cell death to its antioxidant effects.
Few studies have reported that the n acetyl l cysteine inhibits cell death due to its antioxidant effect. No study have been reported which uses N acetyl l cysteine as pulpotomy agent in primary teeth. The motivation behind the study is to evaluate the efficacy of N acetyl l cysteine when used for pulpotomy of primary teeth.Thus this randomised clinical study will be used to evaluate the efficacy of N acetyl l cysteine in pulpotomy of primary molars, among children aged between 5-12 yrs.
The study is based on the hypopthesis that both the N acetyl l cysteine can be used as an alternative material in pulpotomy of primary teeth.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 5.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •patient aged 5-12 years, Deep Carious/mechenical exposure in vital asymptomatic tooth, Tooth free of radicular pulpitis, Presence of atleast 2/3rd of root length.
Exclusion Criteria
- •Presence of absecess,fistula or swelling, Presence of interradicular bone loss, Presence of internal root resorption, Presence of necroyic pulp, Tooth close to natural exfoliation, Mobility of tooth, Pain on percussion.
Outcomes
Primary Outcomes
N acetyl cysteine will show better or equal results as compared to MTA when used as a pulpotomy agent
Time Frame: Evaluation will be done at 3 months, 6 months and 12 months respectively
Secondary Outcomes
- N acetyl cysteine preserves the vitality of remaining radicular pulp, prevents root resorption and has better bactericidal effect as compared to MTA(Evaluation will be done at 3 months, 6 months and 12 months respectively)
Investigators
Sanket Vijay Parmalkar
Pacific Dental College and Hosptial Debari Udaipur