Studying the role of a fetal membranes for treatment of decayed teeth in the mouth.

Completed

• Conditions: Pulpitis,

• Registration Number: CTRI/2022/09/045227
• Lead Sponsor: Saumya Johri

Brief Summary

The current study is a randomized, double-blinded, parallel-group, single-center study. The study will be done in the Department of Endodontics of KGMU, Lucknow. The primary objective is to evaluate the efficacy of freeze-dried, gamma-irradiated amniotic membrane(AM)  in pulpotomy of carious teeth with irreversible pulpitis and to compare it with mineral trioxide aggregate(MTA) that is one of the accepted standard treatment for vital pulp procedures of the teeth. Evaluation will be done by calculating the clinical and radiographical success at 1,3 and 9 months after the procedure.

The amniotic membrane will be availed from the tissue bank of Tata Memorial Hospital, Mumbai. Pro Root MTA from Dentsply(Switzerland) will be the comparator.

The primary outcomes of the study are-

1)Clinical success percentage for both groups.(AM and MTA)

The secondary outcomes of the study are-

1)Radiographical success percentage of both groups.

Time points of evaluation are 1, 3, and 9 months after the procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-15
• Study Completion: 2023-09-21
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 1)Patients between the age 18-35 years who give written consent to participate in the study.
• 2)Permanent molars having pulp exposure due to deep caries.

Exclusion Criteria

• 1)Immature teeth 2)Patients showing clinical signs and symptoms of abscess/fistula, tenderness on percussion, and mobility.
• 3)Teeth showing radiographic signs of periapical pathology, furcation pathology and/or resorption.
• 4. Non-vital teeth.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical success of pulpotomy.	1, 3 and 9 months
Evaluated by absence of signs and symptoms such as pain, inflammation, abscess/sinus, mobility, and crown failure	1, 3 and 9 months

Secondary Outcome Measures

Name	Time	Method
Radiographical success of pulpotomy.	Evaluated by evaluating for pathological internal or external resorption, presence of calcifications and integrity of lamina dura

Trial Locations

Locations (1)

Department of conservative dentistry and endodontics, KGMKU; 🇮🇳 Lucknow, UTTAR PRADESH, India

Department of conservative dentistry and endodontics, KGMKU

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Saumya Johri

Principal investigator

8840854587

saumya.johry@gmail.com