NCT05449938

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

June 1, 2022

Last Update Submit

July 6, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Probing pocket depth

    Change in pocket probing depth from baseline to 6 months

    6 months

  • BLEEDING ON POCKET PROBING (BOPP)

    Change in bleeding on pocket probing depth from baseline to 6 months

    6 months

Study Arms (2)

Thick periodontal phenotype

EXPERIMENTAL

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

Procedure: Scaling and root planing

Thin periodontal phenotype

ACTIVE COMPARATOR

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

Procedure: Scaling and root planing

Interventions

Scaling and root planing involves removal of plaque and calculus on tooth surface.

Thick periodontal phenotypeThin periodontal phenotype

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute Of Dental Science

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Krishan Kant, BDS

    POST GRADUATE INSTITUTE OF DENTAL SCIENCES ROHTAK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajinder Kr Sharma, MDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2022

First Posted

July 8, 2022

Study Start

September 1, 2021

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

July 8, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations