NCT06044727

Brief Summary

Gingival recession is a common condition and its extent and prevalence increase with age. Majority of patients probably present with localized and shallow gingival recession that need a specific treatment because they are susceptible to further apical displacement of gingival margin. So if gingival recession is detected early, removal of causative factors and non surgical treatments initiated then it can prevent more advanced mucogingival defects. Studies have shown that non surgical periodontal therapy including proper oral hygiene instructions, periodic scaling and root planning obtained successful root coverage in shallow gingival recession. Minimal invasive non surgical periodontal therapy (MINST)uses the delicate instruments and magnifying loupes performing periodontal debridement with more effective calculus and biofilm removal and less soft tissue trauma , maintain the tissue architecture, benefit the healing phase, improve the clinical results and increase visibility. There is no study to evaluate efficacy of MINST versus conventional subgingival instrumentation in the restorative capacity of marginal gingival in RT1 gingival recession , so the present study will be conducted to compare and evaluate the efficacy of minimal invasive non surgical periodontal therapy (MINST) and conventional subgingival instrumentation in the restorative capacity of marginal gingiva involving RT1 gingival recession.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.5 years

First QC Date

September 8, 2023

Last Update Submit

August 30, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Recession Depth

    recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at mid labial region.

    6 months

  • Recession Width

    recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.

    6 months

  • Root Coverage %

    Will be calculated according to the formula Root Coverage percentage =Recession depth(preop -postop)\*100/Recession depth preoperative

    6 months

Study Arms (2)

Test group

EXPERIMENTAL

After phase 1 therapy, management of RT1 cases will be done with Minimally invasive non surgical periodontal therapy.

Procedure: Minimally invasive non surgical periodontal therapy

Control Group

ACTIVE COMPARATOR

After phase 1 therapy, management of RT1 cases will be done with Conventional subgingival instrumentation.

Procedure: Conventional subgingival instrumentation

Interventions

using Magnifying loupes

Test group

Conventional subgingival instrumentation

Control Group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gingival Recession Type 1(RT1) by Cairo et al 2011in esthetic zone including maxillary and mandibular anteriors and premolars, otherwise systemically healthy
  • Gingival Recession ≤3mm associated with plaque induced inflammation and identifiable CEJ
  • Age 20 years to 50 years
  • Providing a written and verbal informed consent.

You may not qualify if:

  • Patient with systemic disease that can influence the outcome of therapy.
  • Pregnant females or on oral contraceptive pills or hormone replacement therapy.
  • Smokers and patients undergoing orthodontic therapy
  • Physically and mentally impaired patients.
  • Non vital, mal-positioned tooth
  • Presence of cervical abrasions or restorations in the area
  • Previous history of periodontal surgery on the involved sites.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Anjali Yadav, BDS

    Postgraduate Institute of Dental Sciences Rohtak

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 21, 2023

Study Start

September 25, 2023

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations