Evaluation of Outcomes of Minimally Invasive Non- Surgical Versus Surgical Therapy in Furcation Involvement.

Periodontal Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06025955
• Other study ID #: Nehaperio123
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2024
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: DR. RITIKA ARORA, MDS
• Phone: 9810734445
• Email: drritika44[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: February 28, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Furcation Defects
• Open Flap Debridement
• Periodontal Diseases

Intervention

Procedure:
• minimally invasive non- surgical therapy
hand and ultrasonic instrumentation will be done
• open flap debridement
flap surgery will be done

Locations

Country	Name	City	State
India	Post Graduate Institute of Dental Sciences	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in horizontal clinical attachment level (HCAL)	change in horizontal clinical attachment level (HCAL) of the furcation as assessed	3 months
Primary	change in horizontal clinical attachment level (HCAL)	change in horizontal clinical attachment level (HCAL) of the furcation as assessed	6 months
Secondary	changes in vertical probing depth of the furcation	vertical probing depth will be assessed using UNC 15probe	3 months
Secondary	changes in vertical probing depth of the furcation	vertical probing depth will be assessed using UNC 15probe	6 months
Secondary	change in changes vertical clinical attachment level of furcation	change clinical vertical attachment will be assessed using UNC 15 probe	3 months
Secondary	change in vertical clinical attachment level of furcation	change in vertical clinical attachment level of furcation will be assessed using UNC 15 probe	6 months
Secondary	probing pocket depth (PPD)reduction	probing pocket depth (PPD)reduction will be calculated around the molar at 6 sites	3 months
Secondary	probing pocket depth (PPD)reduction	probing pocket depth (PPD)reduction will be calculated around the molar at 6 sites	6 months