Role of GTR on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication
"Role of Guided Tissue Regeneration on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication: A Randomized Controlled Trial"
1 other identifier
interventional
30
1 country
1
Brief Summary
The recovery of periapical defects linked to periodontal communication frequently yields less satisfactory results. Numerous studies and case reports have highlighted the notable success achieved through the application of guided tissue regeneration techniques. More recently, autologous platelet concentrate plug \& placental membrane have emerged as a treatment option for addressing such lesions. Nevertheless, there has been no study using PRF-Medium with ACM membrane on the healing of aforesaid lesion \& quality of life assessment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2024
CompletedStudy Start
First participant enrolled
May 23, 2024
CompletedFirst Posted
Study publicly available on registry
October 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2025
CompletedJanuary 8, 2025
January 1, 2025
1.6 years
May 22, 2024
January 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Periapical healing assessment
Periapical healing comparison in 2 groups 2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D Criteria. Healing will be categorised into complete, incomplete, uncertain, unsaisfactory.
Base line to 12 months
Secondary Outcomes (1)
Quality of life assessment
Base line to 12 months
Study Arms (2)
Pt with apicomarginal defects & interproximal bone loss receiving GTR
EXPERIMENTALSurgery performed using ACM membrane and PRF plug.
Pt with apicomarginal defects & interproximal bone loss without GTR
ACTIVE COMPARATORSurgery performed without ACM membrane and PRF plug.
Interventions
Surgery performed using ACM membrane and PRF plug in test group \& without membrane \& PRF in control group.
Eligibility Criteria
You may qualify if:
- Patients of age 16yrs and above.
- Patients with apico-marginal defects and deep pocket upto apex of tooth.
- Failed primary root canal treatment.
- Presence of interproximal bone loss.
- Negative response to vitality test.
- ASA-1 or ASA- 2 according to the classification of the American Society of Anesthesiologists)
You may not qualify if:
- Presence of vertical root fracture
- Presence of root perforations
- ASA-3 or ASA-4 according to the classification of the American Society of Anesthesiologists)
- Presence of root resorption
- Combined endodontic-periodontic lesions.
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pgids Rohtak
Haryāna, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr, Sanjay Tewari, MDS
PGIDS, Rohtak, Haryana, 124001
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2024
First Posted
October 16, 2024
Study Start
May 23, 2024
Primary Completion
December 23, 2025
Study Completion
December 23, 2025
Last Updated
January 8, 2025
Record last verified: 2025-01