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

NCT ID: NCT06025955

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2025-02-28

Brief Summary

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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

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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 .

Conditions

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Furcation Defects Open Flap Debridement Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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minimally invasive non surgical therapy

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.

Group Type EXPERIMENTAL

minimally invasive non- surgical therapy

Intervention Type PROCEDURE

hand and ultrasonic instrumentation will be done

open flap debridement

Surgical technique will be used and the full-thickness flap will be minimally elevated. The granulation soft tissue will be dissected with a blade and carefully removed with curettes.

Group Type ACTIVE_COMPARATOR

open flap debridement

Intervention Type PROCEDURE

flap surgery will be done

Interventions

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minimally invasive non- surgical therapy

hand and ultrasonic instrumentation will be done

Intervention Type PROCEDURE

open flap debridement

flap surgery will be done

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neha AGGARWAL, BDS

Role: PRINCIPAL_INVESTIGATOR

PT BD SHARMA UHSR HARAYANA

Locations

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Post Graduate Institute of Dental Sciences

Rohtak, Haryana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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DR. RITIKA ARORA, MDS

Role: CONTACT

9810734445

Facility Contacts

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Shikha Tewari, MDS

Role: primary

Other Identifiers

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Nehaperio123

Identifier Type: -

Identifier Source: org_study_id

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