NCT07576439

Brief Summary

To evaluate the association between the width of keratinized tissue and attached gingiva with root coverage outcomes in RT1 gingival recession defects of maxillary and mandibular anterior teeth treated with subepithelial connective tissue graft using a minimally invasive technique (VISTA + CTG).

  1. 1.PRIMARY OBJECTIVES A. To analyze relation and association at 3 and 6 months outcomes in terms of CRC, mean RC and gingival margin position with baseline parameters including width of keratinized tissue and width of attached gingiva, after providing mucogingival plastic surgery in the form of VISTA+CTG for the treatment of RT1recession defects.
  2. 2.SECONDARY OBJECTIVES A. To access recession depth (RD), recession width (RW), probing pocket depth (PPD), mid buccal clinical attachment loss (b CAL), change in gingival thickness (GT) at baseline, at 3 months and 6 months.
  3. 3.Study design and setting The present clinical trial will be conducted in the department of Periodontics, Post Graduate Institute of Dental Sciences, Rohtak, Haryana.
  4. 4.Study period- up to 24 months
  5. 5.Study subjects INCLUSION CRITERIA
  6. 6.Patients with Millers class Ⅰ and II / RT1 isolated recession defects in labial maxillary and mandibular anterior teeth region.
  7. 7.Recession depth ≥2mm
  8. 8.Systemically healthy individuals.
  9. 9.Age \>18 years old.
  10. 10.Full mouth bleeding and plaque score ≤20%
  11. 11.Patients who agreed to participate in the study and signed an informed consent form.
  12. 12.Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
  13. 13.Patient with active periodontal disease
  14. 14.Smokers and tobacco users
  15. 15.Mal-aligned anterior teeth.
  16. 16.Patients who had already undergone root coverage procedure on the selected site.
  17. 17.Pregnant and lactating females
  18. 18.Involved tooth with trauma from occlusion.
  19. 19.Involved tooth with prosthesis.
  20. 20.Endodontically involved/ RCT treated tooth
  21. 21.Tooth with cervical abrasion / undetectable CEJ/ carious. The sample size was calculated using G\*Power software to achieve 80% statistical power for detecting a significant correlation of r = 0.5 using a linear regression model based on the previously conducted prospective study. The analysis indicated that 26 patients were required. To compensate for an anticipated 10% dropout rate, the sample size was increased, resulting in a final required sample size of 30 participants.

Trial Health

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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
19mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress1%
May 2026Dec 2027

Study Start

First participant enrolled

May 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

May 2, 2026

Last Update Submit

May 2, 2026

Conditions

Keywords

keratinized tissue widthattached gingiva widthRT 1 gingival recession defect

Outcome Measures

Primary Outcomes (1)

  • root coverage

    root coverage will be calculated in percentage

    6 months

Study Arms (1)

treatment of RT1 gingival recession defects using VISTA with connective tissue graft

EXPERIMENTAL
Procedure: Vestibular incision subperiosteal tunnel access with connective tissue graft in treating RT 1 gingival recession defects

Interventions

the aim of this prospective clinical study is to determine if anatomical factors such as keratinized tissue width and attached gingiva width influence recession defects coverage of RT1 recession treated with minimally invasive surgical technique along with connective tissue graft. Keratinized tissue width and attached gingiva width are considered important for maintaining gingival health and long-term stability after root coverage. However, there is limited and unclear evidence on how much keratinized or attached gingiva is actually needed for successful root coverage. Most previous studies have focused on soft tissue thickness rather than these parameters.

treatment of RT1 gingival recession defects using VISTA with connective tissue graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Millers class Ⅰ and II / RT1 isolated recession defects in labial maxillary and mandibular anterior teeth region.
  • Recession depth ≥2mm
  • Systemically healthy individuals.
  • Age \>18 years old.
  • Full mouth bleeding and plaque score ≤20%
  • Patients who agreed to participate in the study and signed an informed consent form.

You may not qualify if:

  • Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
  • Patient with active periodontal disease
  • Smokers and tobacco users
  • Mal-aligned anterior teeth.
  • Patients who had already undergone root coverage procedure on the selected site.
  • Pregnant and lactating females
  • Involved tooth with trauma from occlusion.
  • Involved tooth with prosthesis.
  • Endodontically involved/ RCT treated tooth
  • Tooth with cervical abrasion / undetectable CEJ/ carious

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

  • Richa Tirkey

    PGIDS Rohtak

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2026

First Posted

May 8, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations