Single Sitting SRP vs Supra-gingival Scaling Followed by Sub-gingival SRP After One Week (SRP)

September 27, 2022 updated by: Postgraduate Institute of Dental Sciences Rohtak

Comparative Evaluation of Outcomes of Single Sitting Scaling and Root Planing (SRP) vs Supra-gingival Scaling Followed by Sub-gingival Scaling and Root Planing After One Week: a Split-mouth Randomised Controlled Clinical Trial

The primary course of periodontal treatment is non-surgical periodontal therapy followed by surgical therapy, if required, with an aim to arrest ongoing inflammatory periodontal destruction along with reconstruction of lost apparatus if possible. There is no protocol established for completing scaling and root planing (SRP) in patients with generalized advanced periodontitis. In some cases SRP is completed in single sitting whereas in other cases supragingival scaling is followed by subgingival SRP in the next appointment. It is hypothesized that presence of reparative components near the base of the pocket could result in better treatment outcomes after scaling and root planning done in single sitting when compared to supragingival scaling followed by sub-gingival scaling and root planning after one week.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this randomized controlled clinical trial is to clinically compare the outcomes of scaling and root planing (SRP) completed in single sitting vs supragingival scaling followed by subgingival scaling and root planing after one week in Stage II and Stage III generalised periodontitis patients.

OBJECTIVES:

  1. To assess the improvement in clinical parameters viz. bleeding on pocket probing (BOPP), pocket probing depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), bleeding on marginal probing (BOMP), gingival marginal position (GMP) and gingival recession (GR) by single sitting scaling and root planning versus supragingival scaling followed by subgingival scaling and root planing after one week in Stage II and Stage III generalised periodontitis patients.
  2. To assess the correlation between availability of Vascular Endothelial Growth Factor (VEGF) at the base of the pocket and treatment outcomes.

SETTING: Department of Periodontology and Oral Implantology, PGIDS, Rohtak, Haryana.

STUDY DESIGN: Split-mouth Randomized controlled clinical trial.

TIME FRAME: 12 months

POPULATION: Systemically healthy patients with Stage II and Stage III Generalised Periodontitis with more than 20 teeth present.

SAMPLE SIZE: To be able to detect a clinically meaningful difference of 1mm and 10% improvement in PPD and BOPP respectively between groups, assuming an effect size of 0.85 with a power of 80% and 5% level of significance, a minimum sample size of 22 patients are needed in each group. Accounting for a 20% drop out rate, 27 patients are needed in each group.

METHODOLOGY: Patients with stage II and III generalised periodontitis will be recruited from the outpatient Department of Periodontology, PGIDS, Rohtak. Patients fulfilling the eligibility criteria will be enrolled in the study after obtaining an informed written consent. A split-mouth design will be chosen using two contra-lateral quadrants per group being randomly assigned into test (single sitting SRP) and control (supragingival scaling followed by subgingival scaling after a week) group for each patient using a chit-method.

Study Type

Interventional

Enrollment (Anticipated)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Haryana
      • Rohtak, Haryana, India, 124001
        • Recruiting
        • PGIDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

•Systemically healthy patients with Stage II and Stage III Generalised Periodontitis with more than 20 teeth present.

Exclusion Criteria:

  • Systemic illness known to affect the periodontium or outcome of periodontal therapy.
  • Mobile teeth (Mobility no. 2 and 3 as per Miller Index)
  • Patient taking medications such as NSAIDS, corticosteroids, statins or calcium channel blockers, which are known to interfere with periodontal wound healing.
  • Pregnant or lactating women.
  • History of use of tobacco.
  • History of periodontal treatment in last 2 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEST GROUP
INTERVENTION: Scaling and root planning (SRP) of two contra-lateral quadrants (randomly allocated) in single sitting with ultrasonic scaler, hand scalers and curettes under local anaesthesia.
Procedure: SCALING AND ROOT PLANING (SRP)in single sitting
SCALING AND ROOT PLANING (SRP) IS THE PRIMARY COURSE OF NON-SURGICAL PERIODONTAL TREATMENT THAT INVOLVES REMOVAL OF SUPRA-GINGIVAL AND SUB-GINGIVAL BIOFILM AND CALCULUS FOLLOWED BY THOROUGH ROOT PLANING.
Active Comparator: CONTROL GROUP
INTERVENTION: Supra-gingival scaling followed by sub-gingival scaling and root planing of two contra-lateral quadrants (randomly allocated) in two sittings with ultrasonic scaler, hand scalers and curettes under local anaesthesia.
Procedure: SCALING AND ROOT PLANING (SRP)in two sittings
SCALING AND ROOT PLANING (SRP) IS THE PRIMARY COURSE OF NON-SURGICAL PERIODONTAL TREATMENT THAT INVOLVES REMOVAL OF SUPRA-GINGIVAL AND SUB-GINGIVAL BIOFILM AND CALCULUS FOLLOWED BY THOROUGH ROOT PLANING.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bleeding on pocket probing (BOPP)
Time Frame: 6 MONTHS
CHANGE IN BLEEDING ON POCKET PROBING FROM BASELINE TO 6 MONTHS
6 MONTHS
Chane in pocket probing depth (PPD)
Time Frame: 6 MONTHS
CHANGE IN POCKET PROBING DEPTH FROM BASELINE TO 6 MONTHS
6 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Investigators

  • Principal Investigator: AANCHAL SAHNI, BDS, Post Graduate Institute Of Dental Sciences,Rohtak

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

May 28, 2022

First Submitted That Met QC Criteria

July 7, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AANCHAL SAHNI PERIO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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