NCT04255914

Brief Summary

To predict root coverage in Miller class III gingival recessions in chronic periodontitis patients using interdisciplinary orthodontic-periodontal surgical treatment as compared to periodontal surgical treatment alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

February 3, 2020

Last Update Submit

August 19, 2022

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • root coverage

    percentage of root coverage by calculating recession depth preoperatively and postoperatively

    12 months

Secondary Outcomes (1)

  • bleeding on probing

    12 months

Study Arms (2)

Root coverage procedure along with orthodontic treatment

EXPERIMENTAL

subepithelial connective tissue graft and orthodontic levelling and alignment

Procedure: Periodontal plastic surgery procedure and orthodontic treatment

Root coverage procedure only

ACTIVE COMPARATOR

sub epithelial connective tissue graft procedure for recession coverage

Procedure: Periodontal plastic surgery procedure

Interventions

Periodontal plastic surgery procedure and orthodontic treatmentPROCEDURE

subepithelial connective tissue graft and orthodontic tooth levelling and alignment

Root coverage procedure along with orthodontic treatment
Periodontal plastic surgery procedurePROCEDURE

subepithelial connective tissue graft procedure

Root coverage procedure only

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35 years.
  • Anterior tooth displaying Miller's class III gingival recession / RT2, with malposition which required orthodontic treatment.
  • Presence of clinically identifiable cementoenamel junction.
  • Patient demonstrating compliance for maintaining good oral hygiene after Phase I treatment (evaluated using plaque index \< 1%).

You may not qualify if:

  • Patient having any systemic illness (such as diabetes, hyperthyroidism, autoimmune diseases, etc.) that is known to affect the periodontium or outcome of periodontal treatment.
  • Aggressive Periodontitis.
  • Patients taking medications which are known to interfere with periodontal wound healing such as corticosteroids, calcium channel blockers or long-term NSAIDS.
  • Pregnant or lactating women.
  • Cervically restored teeth and the presence of severe cervical abrasion, erosion or root caries.
  • Non vital tooth.
  • Current and past smokers.
  • Patients with oral piercing.
  • Mobile teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

Related Publications (1)

  • Malhotra S, Tewari S, Sharma R, Sharma RK, Tanwar N, Arora R. Clinical evaluation of root coverage in Miller class III/RT2 labial gingival recession treated with interdisciplinary periodontal-orthodontic therapy: a randomized controlled clinical trial. J Periodontal Implant Sci. 2024 Aug;54(4):265-279. doi: 10.5051/jpis.2204100205. Epub 2023 Nov 20.

    PMID: 38290996DERIVED

MeSH Terms

Conditions

Gingival Recession

Interventions

Orthodontics

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • SAKSHI MALHOTRA

    POST GRADUATE INSTITUTE OF DENTAL SCIENCES,ROHTAK

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 5, 2020

Study Start

February 1, 2020

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

August 23, 2022

Record last verified: 2022-08

Locations

IN(1)