Clinical trial NCT06025955: Evaluation of Outcomes of Minimally Invasive Non- Surgical Versus Surgical Therapy in Furcation Involvement.
Official title: Evaluation of Outcomes of Minimally Invasive Non- Surgical Versus Surgical Therapy in Patients With Furcation Involvement in Mandibular Molars - A Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Furcation Defects
Open Flap Debridement
Periodontal Diseases
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The reduced rate of success experienced in the treatment of Furcation involvement (FI) seems to result from the incomplete removal of subgingival plaque and calculus in the interradicular area owing to the peculiar anatomy of the furcation space.

Regarding the therapeutic approach, although FI treated with a conservative approach may not yield the same satisfactory results as single rooted teeth; it has been shown that teeth with FI have a remarkable survival rate following conservative treatment in patients demonstrating a satisfactory plaque control. Minimally invasive techniques aim to retain the preoperative gingival architecture, create a minimal wound and gently handle soft and hard tissues. It becomes imperative to see the differences in clinical, and patient centered outcomes of minimally invasive non- surgical versus surgical technique in the management of furcation involvement in mandibulae molar.

Detailed description: Patients will be recruited from outpatient clinic of Department of Periodontics, PGIDS, Rohtak after screening based on given inclusion and exclusion criteria. after initial session of scaling and root planing patient will be re -elevated at the and of 6 to 8 weeks those having grade 2 furcation involvement in any mandibular molar and meeting other eligibility criteria will be randomly allocated to test group and control group Test group -Experimental sites designated to receive non-surgical treatment will be submitted to careful subgingival debridement using curettes and ultrasonic device using 3.5 x magnification.

control group-Surgical technique will be followed with minimally flap reflection and incisions will be performed with papilla preservation techniques. vertical- releasing incisions will not be made, and the full-thickness flap will be minimally elevated. The granulation soft tissue will be dissected with a blade and carefully removed with curettes. The visible calculus will be carefully removed with curettes and an ultrasonic device. The flaps will be re-positioned and sutured and patient follow up 3 to 6 months .

Eligibility criteria: Inclusion Criteria:

* Systemically healthy patients with diagnosis of generalized stage 3 periodontitis (Grade A or B) with at least one mandibular molar with FI (Degree 1 or 2-according to Hamp, 1975 and Subclass A or B- according to Tarnow and Fletcher, 1984), interproximal bone coronal to the furcation fornix and root trunk length ≤ cervical two thirds of the root length as measured on a periapical radiograph.
* Full mouth plaque score \< 30% after initial therapy
* Full mouth bleeding score \< 30% after initial therapy
* Having undergone a course of subgingival instrumentation in the past three months

Exclusion Criteria:

* Pregnant or lactating females
* Requiring antibiotic premedication
* Received antibiotic treatment in the previous 3 months
* Previous periodontal surgery in the last 1 year
* Smokers
* Pulpal or periapical pathology
* Third molar
* Non restorable tooth
* Trauma from occlusion

Primary outcomes:
measure: change in horizontal clinical attachment level (HCAL)
timeFrame: 3 months
measure: change in horizontal clinical attachment level (HCAL)
timeFrame: 6 months
Secondary outcomes:
measure: changes in vertical probing depth of the furcation
timeFrame: 3 months
measure: changes in vertical probing depth of the furcation
timeFrame: 6 months
measure: change in changes vertical clinical attachment level of furcation
timeFrame: 3 months
measure: change in vertical clinical attachment level of furcation
timeFrame: 6 months
measure: probing pocket depth (PPD)reduction
timeFrame: 3 months
measure: probing pocket depth (PPD)reduction
timeFrame: 6 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
Study officials:
affiliation: PT BD SHARMA UHSR HARAYANA
name: Neha AGGARWAL, BDS
role: PRINCIPAL_INVESTIGATOR
References: