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Periodontal Phenotype and Scaling and Root Planing

Primary Purpose

Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Scaling and root planing
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Systemically healthy patients with periodontitis (periodontitis stage 2 and stage 3) and thin/thick periodontal phenotype in maxillary and mandibular incisors will be included.

Exclusion Criteria:

  • Systemic condition known to affect the course of periodontal disease like diabetes mellitus or immunogenic disorders.
  • Patient on anti-inflammatory drugs or antibiotics or history of treatment with medication known to influence periodontal status or healing within last 2 years.
  • Current or former smoker or use of tobacco in any form
  • History of periodontal treatment in last 2 years
  • Crowding in anterior teeth.
  • Pregnant or lactating females.
  • Individuals with restorations on anterior teeth.

Sites / Locations

  • Post Graduate Institute Of Dental ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thick periodontal phenotype

Thin periodontal phenotype

Arm Description

Stage II and stage III periodontitis Patient with thick periodontal phenotype will be enrolled using probe transparency method .

Stage II and stage III periodontitis Patient with thin periodontal phenotype will be enrolled using probe transparency method.

Outcomes

Primary Outcome Measures

Probing pocket depth
Change in pocket probing depth from baseline to 6 months
BLEEDING ON POCKET PROBING (BOPP)
Change in bleeding on pocket probing depth from baseline to 6 months

Secondary Outcome Measures

Full Information

First Posted
June 1, 2022
Last Updated
July 6, 2022
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT05449938
Brief Title
Periodontal Phenotype and Scaling and Root Planing
Official Title
Clinical Evaluation of Impact of Periodontal Phenotype on the Outcome of Scaling and Root Planing in Patients With Periodontitis: A Comparative Interventional Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
August 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
No

5. Study Description

Brief Summary
Periodontal phenotype has been recognized as one of the key factors that may potentially impact the outcome of a variety of periodontal surgical and non-surgical procedures. Taking into consideration the inconsistent findings of the studies done in this regard,outcomes of scaling and root planing with respect to periodontal phenotype. With this aim, the present study would be conducted to assess the influence of periodontal phenotype on outcome of scaling and root planing in periodontitis patients.
Detailed Description
AIM: To evaluate the influence of periodontal phenotype on the outcomes of scaling and root planing in periodontitis patients. OBJECTIVES: To assess the improvement in pocket probing depth (PPD), clinical attachment level (CAL), bleeding in pocket probing (BOPP), bleeding on marginal probing (BOMP), gingival marginal position (GMP), gingival recession (GR), plaque index (PI), and gingival index (GI) after scaling and root planing (SRP) in periodontitis patients with thin or thick periodontal phenotype. SETTING: Department of periodontics and oral implantology, PGIDS, Rohtak, Haryana. STUDY DESIGN: Comparative Interventional study. TIME FRAME: 12 months (september 2021- August 2022) POPULATION: Systemically healthy patients with periodontitis (periodontitis stage II and stage III) and thin/thick periodontal phenotype in maxillary and mandibular incisors will be included.

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
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thick periodontal phenotype
Arm Type
Experimental
Arm Description
Stage II and stage III periodontitis Patient with thick periodontal phenotype will be enrolled using probe transparency method .
Arm Title
Thin periodontal phenotype
Arm Type
Active Comparator
Arm Description
Stage II and stage III periodontitis Patient with thin periodontal phenotype will be enrolled using probe transparency method.
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Intervention Description
Scaling and root planing involves removal of plaque and calculus on tooth surface.
Primary Outcome Measure Information:
Title
Probing pocket depth
Description
Change in pocket probing depth from baseline to 6 months
Time Frame
6 months
Title
BLEEDING ON POCKET PROBING (BOPP)
Description
Change in bleeding on pocket probing depth from baseline to 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Systemically healthy patients with periodontitis (periodontitis stage 2 and stage 3) and thin/thick periodontal phenotype in maxillary and mandibular incisors will be included. Exclusion Criteria: Systemic condition known to affect the course of periodontal disease like diabetes mellitus or immunogenic disorders. Patient on anti-inflammatory drugs or antibiotics or history of treatment with medication known to influence periodontal status or healing within last 2 years. Current or former smoker or use of tobacco in any form History of periodontal treatment in last 2 years Crowding in anterior teeth. Pregnant or lactating females. Individuals with restorations on anterior teeth.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rajinder Kr Sharma, MDS
Phone
9416358222
Email
rksharmamds@yahoo.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krishan Kant, BDS
Organizational Affiliation
POST GRADUATE INSTITUTE OF DENTAL SCIENCES ROHTAK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Post Graduate Institute Of Dental Science
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, MDS
Phone
01262283876
Email
principalpgids@yahoo.in
First Name & Middle Initial & Last Name & Degree
Ambika Gupta, MDS

12. IPD Sharing Statement

Plan to Share IPD
No

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Periodontal Phenotype and Scaling and Root Planing

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