Single Sitting SRP vs Supra-gingival Scaling Followed by Sub-gingival SRP After One Week (SRP)
Primary Purpose
Periodontitis
Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
SCALING AND ROOT PLANING (SRP)in single sitting
SCALING AND ROOT PLANING (SRP)in two sittings
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
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.
Sites / Locations
- PGIDSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TEST GROUP
CONTROL GROUP
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in bleeding on pocket probing (BOPP)
CHANGE IN BLEEDING ON POCKET PROBING FROM BASELINE TO 6 MONTHS
Chane in pocket probing depth (PPD)
CHANGE IN POCKET PROBING DEPTH FROM BASELINE TO 6 MONTHS
Secondary Outcome Measures
Full Information
NCT ID
NCT05449964
First Posted
May 28, 2022
Last Updated
September 27, 2022
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
1. Study Identification
Unique Protocol Identification Number
NCT05449964
Brief Title
Single Sitting SRP vs Supra-gingival Scaling Followed by Sub-gingival SRP After One Week
Acronym
SRP
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TEST GROUP
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL GROUP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
SCALING AND ROOT PLANING (SRP)in single sitting
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
SCALING AND ROOT PLANING (SRP)in two sittings
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in bleeding on pocket probing (BOPP)
Description
CHANGE IN BLEEDING ON POCKET PROBING FROM BASELINE TO 6 MONTHS
Time Frame
6 MONTHS
Title
Chane in pocket probing depth (PPD)
Description
CHANGE IN POCKET PROBING DEPTH FROM BASELINE TO 6 MONTHS
Time Frame
6 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RAJINDER KR SHARMA, MDS
Phone
01262-283876
Email
rksharmamds@yahoo.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AANCHAL SAHNI, BDS
Organizational Affiliation
POST GRADUATE INSTITUTE OF DENTAL SCIENCES,ROHTAK
Official's Role
Principal Investigator
Facility Information:
Facility Name
PGIDS
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay Tewari
Phone
01262283876
Email
principalpgids@yahoo.in
First Name & Middle Initial & Last Name & Degree
Ambika Gupta
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Single Sitting SRP vs Supra-gingival Scaling Followed by Sub-gingival SRP After One Week
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