NCT05449964

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.

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
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

September 28, 2022

Status Verified

July 1, 2022

Enrollment Period

1.2 years

First QC Date

May 28, 2022

Last Update Submit

September 27, 2022

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (2)

  • Change in bleeding on pocket probing (BOPP)

    CHANGE IN BLEEDING ON POCKET PROBING FROM BASELINE TO 6 MONTHS

    6 MONTHS

  • Chane in pocket probing depth (PPD)

    CHANGE IN POCKET PROBING DEPTH FROM BASELINE TO 6 MONTHS

    6 MONTHS

Study Arms (2)

TEST GROUP

EXPERIMENTAL

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

CONTROL GROUP

ACTIVE COMPARATOR

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

Interventions

SCALING AND ROOT PLANING (SRP)in single sittingPROCEDURE

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.

TEST GROUP
SCALING AND ROOT PLANING (SRP)in two sittingsPROCEDURE

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.

CONTROL GROUP

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

RECRUITING

Related Publications (1)

  • Sahni A, Sharma RK, Tewari S, Gill PS, Arora R. Impact of supragingival scaling on the outcomes of subgingival instrumentation completed after 1 week: a split-mouth randomized clinical trial. Quintessence Int. 2023 Oct 19;54(9):724-733. doi: 10.3290/j.qi.b4168461.

    PMID: 37334784DERIVED

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

  • AANCHAL SAHNI, BDS

    POST GRADUATE INSTITUTE OF DENTAL SCIENCES,ROHTAK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

RAJINDER KR SHARMA, MDS

CONTACT

01262-283876rksharmamds@yahoo.in

Study Design

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

Study Record Dates

First Submitted

May 28, 2022

First Posted

July 8, 2022

Study Start

August 1, 2021

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

September 28, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)