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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06025955
Other study ID # Nehaperio123
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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