NCT06000228

Brief Summary

Aim of this study is to assess the influence of vestibular depth on root coverage in Miller class III/ Cairo RT2 gingival recession when treated with minimally invasive technique using connective tissue graft.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

First Submitted

Initial submission to the registry

August 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

August 12, 2023

Last Update Submit

January 11, 2024

Conditions

Gingival Recession, Localized

Outcome Measures

Primary Outcomes (1)

  • percentage root coverage

    percentage of root coverage is calculated using formula: Preoperative recession depth-postoperative recession depth/ preoperative recession depth × 100

    12-14 months

Study Arms (2)

Shallow vestibule

EXPERIMENTAL

Miller class III/ RT2 labial gingival recession associated with vestibular depth less than 6mm

Procedure: Recession coverage with CTG using minimally invasive access technique in shallow vestibule

Deep vestibule

ACTIVE COMPARATOR

Miller class III/ RT2 labial gingival recession associated with vestibular depth more than 6mm

Procedure: Recession coverage with CTG using minimally invasive access technique in deep vestibule

Interventions

Recession coverage with CTG using minimally invasive access technique in shallow vestibulePROCEDURE

After enrolment, participants will be instructed about oral hygiene and undergo nonsurgical periodontal treatment in the form of scaling and root planing using ultrasonic and hand instruments as needed. After resolution of inflammation, a full thickness tunnel will be preapred using minimally invasive access technique under local anesthesia with the aid of specific tunnelling instruments and connective tissue graft will be procured from the palate or tuberosity area for root coverage procedure by single incision technique.

Shallow vestibule
Recession coverage with CTG using minimally invasive access technique in deep vestibulePROCEDURE

After enrolment, participants will be instructed about oral hygiene and undergo nonsurgical periodontal treatment in the form of scaling and root planing using ultrasonic and hand instruments as needed. After resolution of inflammation, a full thickness tunnel will be preapred using minimally invasive access technique under local anesthesia with the aid of specific tunnelling instruments and connective tissue graft will be procured from the palate or tuberosity area for root coverage procedure by single incision technique.

Deep vestibule

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients (≥18 years) presenting with isolated Miller class III / Cairo RT2 labial gingival recession defect with deep and shallow vestibular defect.
  • Absence of clinical tooth mobility.
  • Age \>18 years old.
  • A full mouth plaque index and full mouth bleeding index \< 20%
  • Patient showing adequate compliance and willing to participate in the study.
  • CAL (clinical attachment level), RD (recession depth) and KTW (keratinized tissue depth) will be comparable and matched in both the groups.

You may not qualify if:

  • (1) full-mouth plaque and bleeding score \>20%; (2) non smoker; (3) systemic contraindications for periodontal surgery; (4) taking medications known to affect gingival homeostasis or interfere with wound healing; (5) pregnancy; (6) active orthodontic therapy; (7) previous periodontal surgery, caries, or restorations in the experimental site(s); and (8) malpositioned /crowded teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shikha Tewari

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • sushma Kumari, BDS

    Postgraduate Institute of Dental Sciences Rohtak

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjay Tewari, MDS

CONTACT

01262213876principalpgids@yahoo.in

Shikha Tewari, MDS

CONTACT

9416514600drshikhatewari@yahoo.com

Study Design

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

Study Record Dates

First Submitted

August 12, 2023

First Posted

August 21, 2023

Study Start

September 15, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)