Actively Recruiting
Role of Guided Tissue Regeneration on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication: A Randomized Controlled Trial
Led by Postgraduate Institute of Dental Sciences Rohtak · Updated on 2025-01-08
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the healing outcomes and quality of life in patients with apico-marginal defects and interproximal involvement related to endodontic and periapical diseases. The study compares the combined use of PRF-Medium plug and acellular chorionic membrane (ACM) with conventional endodontic surgery techniques. It focuses on patients with non-vital teeth suffering from chronic suppurative apical periodontitis and persistent defects, assessing whether this new combination improves recovery and patient wellbeing. Participants will undergo endodontic micro-surgery, where one group receives surgery with the placement of PRF-Medium plug and ACM membrane, while the comparison group undergoes surgery without these materials. The study involves two groups: one treated with guided tissue regeneration (GTR) using the ACM membrane and PRF plug, and the other with surgery alone. The interventions are randomized, and the study employs triple masking to reduce bias. Throughout the 12 months following surgery, participants will be monitored with 2D periapical radiographs and 3D cone-beam computed tomography (CBCT) imaging to assess periapical healing. Quality of life assessments are also conducted from baseline to 12 months to evaluate patient outcomes. The study includes regular follow-ups to measure healing progress and patient-reported wellbeing, with the total participation duration being one year.
CONDITIONS
Brief Title
Role of GTR on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 16 years and above
- Patients with apico-marginal defects and deep pockets up to the apex of the tooth
- Failed primary root canal treatment
- Presence of interproximal bone loss
- Negative response to vitality test
- Classified as ASA-1 or ASA-2 according to the American Society of Anesthesiologists
You will not qualify if you...
- Presence of vertical root fracture
- Presence of root perforations
- Classified as ASA-3 or ASA-4 according to the American Society of Anesthesiologists
- Presence of root resorption
- Combined endodontic-periodontic lesions
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus immediate recovery period
Participants undergo endodontic micro-surgery with or without the use of ACM membrane and PRF plug depending on group assignment.
1 surgical visit and several immediate post-operative visits
Duration - Up to 12 months
Participants are monitored for healing outcomes and quality of life after surgery.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Pgids Rohtak
Haryāna, India
Actively Recruiting
Research Team
D
Dr. Shweta Mittal, MDS
D
Dr. Parichay Singhal, MDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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