Influence of Keratinized Tissue Width and Attached Gingiva Width on Root Coverage in Patients With Recession Defects: A Prospective Clinical Study
1 other identifier
interventional
30
1 country
1
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.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.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.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.Study period- up to 24 months
- 5.Study subjects INCLUSION CRITERIA
- 6.Patients with Millers class Ⅰ and II / RT1 isolated recession defects in labial maxillary and mandibular anterior teeth region.
- 7.Recession depth ≥2mm
- 8.Systemically healthy individuals.
- 9.Age \>18 years old.
- 10.Full mouth bleeding and plaque score ≤20%
- 11.Patients who agreed to participate in the study and signed an informed consent form.
- 12.Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
- 13.Patient with active periodontal disease
- 14.Smokers and tobacco users
- 15.Mal-aligned anterior teeth.
- 16.Patients who had already undergone root coverage procedure on the selected site.
- 17.Pregnant and lactating females
- 18.Involved tooth with trauma from occlusion.
- 19.Involved tooth with prosthesis.
- 20.Endodontically involved/ RCT treated tooth
- 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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2026
1 active site
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 Start
First participant enrolled
May 1, 2026
CompletedFirst Submitted
Initial submission to the registry
May 2, 2026
CompletedFirst Posted
Study publicly available on registry
May 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
May 8, 2026
May 1, 2026
1.6 years
May 2, 2026
May 2, 2026
Conditions
Keywords
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
EXPERIMENTALInterventions
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richa Tirkey
PGIDS Rohtak
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