Influence of Keratinized Tissue Width and Attached Gingiva Width on Root Coverage in Patients With Recession Defects: A Prospective Clinical Study
NCT07576439 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-08
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.
B. To evaluate 3 and 6 months outcomes (percentage of root coverage, 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.
C. To access the long-term stability of gingival margin achieved from 3 months to 6 months
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.
B. To access patient related outcomes measures (PROM) in pain and hypersensitivity in teeth with gingival recession undergoing recession coverage.
Details of Methodology
1. Study design and setting The present clinical trial will be conducted in the department of Periodontics, Post Graduate Institute of Dental Sciences, Rohtak, Haryana.
2. Study period- up to 24 months
3. Study subjects INCLUSION CRITERIA
1. Patients with Millers class Ⅰ and II / RT1 isolated recession defects in labial maxillary and mandibular anterior teeth region.
2. Recession depth ≥2mm
3. Systemically healthy individuals.
4. Age \>18 years old.
5. Full mouth bleeding and plaque score ≤20%
6. Patients who agreed to participate in the study and signed an informed consent form.
EXCLUSION CRITERIA
1. Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
2. Patient with active periodontal disease
3. Smokers and tobacco users
4. Mal-aligned anterior teeth.
5. Patients who had already undergone root coverage procedure on the selected site.
6. Pregnant and lactating females
7. Involved tooth with trauma from occlusion.
8. Involved tooth with prosthesis.
9. Endodontically involved/ RCT treated tooth
10. 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.
e. Method of recruitment The study will recruit systematically healthy patients exhibiting Millers class Ⅰ and Ⅱ or RT1 recession defects in maxillary and mandibular anterior teeth from the periodontology outpatient department.
f. Intervention Scaling and root planing Following selection, all the patients will be subjected to phase I therapy, which included full mouth scaling and root planing using ultrasonic scalers and hand instrumentation.
Surgical procedure Connective Tissue Graft Harvesting (Single Incision Technique - Hurzeler et al., After local anesthesia, a single horizontal incision was made 2 mm from the gingival margin of maxillary premolars using a #15 blade (90° to bone). A partial thickness dissection was performed through the same incision to create an undermined area of required size. The connective tissue graft was then outlined with mesial, distal, and medial incisions, separated, and removed using a periosteal elevator. The donor site was closed with horizontal suspension sutures.
VISTA Technique :
After local anesthesia and root planing, a small vestibular incision was made near the MGJ using a 15C blade. A full-thickness subperiosteal tunnel was created and extended beneath adjacent papillae. An SCTG was inserted through the incision, positioned under the recession area, and the gingivo-papillary complex was coronally advanced and secured with 5-0 polyglactin sutures.
Post operative care Suitable antibiotics and analgesics will be prescribed for 5 days. Chlorhexidine (0.12%) mouthwash for a week. The Coronally attached bonded sutures will be removed after 3 weeks. Follow up All patients will be recalled for recording of all the clinical parameters at 3and 6 months.
Conditions
- Gingival Recessions
Interventions
- PROCEDURE
-
Vestibular incision subperiosteal tunnel access with connective tissue graft in treating RT 1 gingival recession defects
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.
Sponsors & Collaborators
-
Postgraduate Institute of Dental Sciences Rohtak
lead OTHER
Principal Investigators
-
Richa Tirkey · PGIDS Rohtak
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- India
Study Locations
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