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Clinical Trials/NCT06044727
NCT06044727CompletedNot Applicable

Comparative Evaluation Of the Restorative Capacity Of Marginal Gingiva Using MINST and Conventional Subgingival Instrumentation Involving RT1 Gingival Recession: A Randomized Controlled Clinical Trial

Postgraduate Institute of Dental Sciences Rohtak2 sites in 1 country54 target enrollmentStarted: September 25, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
54
Locations
2
Primary Endpoint
Root Coverage %

Study Overview

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.

Detailed Description

TITLE:

"Comparative Evaluation Of the Restorative Capacity Of Marginal Gingiva Using Minimal Invasive Non-Surgical Periodontal Therapy and Conventional Subgingival Instrumentation Involving RT1 Gingival Recession : A Randomized controlled clinical trial."

RATIONALE:

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 treatment 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 evaluate the same.

AIM:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Root Coverage %

Time Frame: 6 months

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

Recession Width

Time Frame: 6 months

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

Recession Depth

Time Frame: 6 months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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