Gingival RecessionsNCT07576439
Influence of Keratinized Tissue Width and Attached Gingiva Width on Root Coverage in Patients With Recession Defects: A Prospective Clinical Study
A study testing Vestibular incision subperiosteal tunnel access with connective tissue graft in treating RT 1 gingival recession defects in people with Gingival Recessions, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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 (CTG) using a minimally invasive technique : modified vestibular incision… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gingival Recessions
- What is being tested?
- Vestibular incision subperiosteal tunnel access with connective tissue graft in treating RT 1 gingival recession defects
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 tooth with recession.
- Patients who had already undergone root coverage procedure on the selected site.
- Pregnant and lactating females
Show all 10Show fewer
- Involved tooth with trauma from occlusion.
- Involved tooth with prosthesis.
- Endodontically involved/ RCT treated tooth
- Tooth with cervical abrasion / undetectable CEJ/ carious
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tewari contact
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
Shikha Tewari, MDS, +919416514600, drshikhatewari@yahoo.com
Richa Tirkey, BDS, +918210892921, richatirkey16@gmail.com
About this study
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 (CTG) using a minimally invasive technique : modified vestibular incision subperiosteal tunnel access(m-VISTA).
OBJECTIVES
- PRIMARY OBJECTIVES
- To analyze relation and association at 3 and 6 months outcomes in terms of CRC, mRC 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 m-VISTA+CTG for the treatment of RT1recession defects.
- 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 m-VISTA+CTG for the treatment of RT1recession defects.
- To access the long-term stability of gingival margin achieved from 3 months to 6 months.
- SECONDARY OBJECTIVES
- To access recession depth (RD), recession width (RW), probing pocket depth (PPD), mid buccal clinical attachment loss (bCAL), change in gingival thickness (GT) at baseline, at 3 months and 6 months.
- To access patient related outcomes measures (PROM) in pain and hypersensitivity in teeth with gingival recession undergoing recession coverage.
Read the detailed description
Recent longitudinal evidence suggests that soft tissue thickness may play a more decisive role in long-term stability than keratinized tissue width (KTW) alone. The baseline keratinized tissue width necessary to achieve stable outcomes remain lacking as the scarcity of cases presenting with minimal or no keratinized tissue width limited the exploration of its influence on achieving complete root coverage in scenarios characterized by extremely reduced or absent keratinized tissue width.
Furthermore, attached gingiva width (AGW) has been insufficiently studied despite its proposed biological relevance in providing functional connective tissue attachment to the underlying hard tissues. In recent randomized controlled trial attached gingiva width was considered along with root coverage percentage as a primary outcome in evaluating collagen matrix (CM) versus connective tissue graft with modified coronally advanced tunnel technique in isolated RT1 cases. A recent study in which anatomical factors affecting root coverage among mandibular incisors were studied and presented limitations such as restricted inclusion of sites, presenting type of recession defects and limited cases with minimal or absent keratinized tissue, thereby limiting its ability to define its absolute indication or minimum requirement for successful root coverage. Collectively, these limitations were particularly related to inclusion of mandibular sites. On perusal of literature revealed there is no prospective study in which baseline keratinized tissue width and attached gingiva width as prognostic factors for root coverage were studied.
Therefore, 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.
Details of Methodology
- Study design and setting The present clinical trial will be conducted in the department of Periodontics, Post Graduate Institute of Dental Sciences, Rohtak, Haryana.
- Study period- up to 24 months
- Study subjects 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.
- 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.
- 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) 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.
m-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 monofilament 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
- Being tested
- Vestibular incision subperiosteal tunnel access with connective tissue graft in treating RT 1 gingival recession defects
- Keywords
- keratinized tissue width, attached gingiva width, RT 1 gingival recession defect
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular incision subperiosteal tunnel access with connective tissue graft in treating RT 1 gingival recession defectsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment of RT1 gingival recession defects using m-VISTA with connective tissue graft | Experimental | Not described Receives: Procedure: Vestibular incision subperiosteal tunnel access with connective tissue graft in treating RT 1 gingival recession defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
root coverage
root coverage will be calculated in percentage
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richa Tirkey, Principal investigator, PGIDS Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576439
- Sponsor's protocol ID
- Dr. Richa Tirkey Periodontics
- Status last verified
- Sep 2026
- First submitted
- 2 May 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Keratinized Tissue Width and Attached Gingiva Width on Root Coverage in Patients With Recession Defects: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07576439
- Acronym / sponsor ID
- Dr. Richa Tirkey Periodontics
- Conditions
- Gingival Recessions
- Keywords
- keratinized tissue width, attached gingiva width, RT 1 gingival recession defect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (CTG) using a minimally invasive technique : modified vestibular incision subperiosteal tunnel access(m-VISTA).
OBJECTIVES
- PRIMARY OBJECTIVES
- To analyze relation and association at 3 and 6 months outcomes in terms of CRC, mRC 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 m-VISTA+CTG for the treatment of RT1recession defects.
- 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 m-VISTA+CTG for the treatment of RT1recession defects.
- To access the long-term stability of gingival margin achieved from 3 months to 6 months.
- SECONDARY OBJECTIVES
- To access recession depth (RD), recession width (RW), probing pocket depth (PPD), mid buccal clinical attachment loss (bCAL), change in gingival thickness (GT) at baseline, at 3 months and 6 months.
- To access patient related outcomes measures (PROM) in pain and hypersensitivity in teeth with gingival recession undergoing recession coverage.
Detailed description
Recent longitudinal evidence suggests that soft tissue thickness may play a more decisive role in long-term stability than keratinized tissue width (KTW) alone. The baseline keratinized tissue width necessary to achieve stable outcomes remain lacking as the scarcity of cases presenting with minimal or no keratinized tissue width limited the exploration of its influence on achieving complete root coverage in scenarios characterized by extremely reduced or absent keratinized tissue width.
Furthermore, attached gingiva width (AGW) has been insufficiently studied despite its proposed biological relevance in providing functional connective tissue attachment to the underlying hard tissues. In recent randomized controlled trial attached gingiva width was considered along with root coverage percentage as a primary outcome in evaluating collagen matrix (CM) versus connective tissue graft with modified coronally advanced tunnel technique in isolated RT1 cases. A recent study in which anatomical factors affecting root coverage among mandibular incisors were studied and presented limitations such as restricted inclusion of sites, presenting type of recession defects and limited cases with minimal or absent keratinized tissue, thereby limiting its ability to define its absolute indication or minimum requirement for successful root coverage. Collectively, these limitations were particularly related to inclusion of mandibular sites. On perusal of literature revealed there is no prospective study in which baseline keratinized tissue width and attached gingiva width as prognostic factors for root coverage were studied.
Therefore, 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.
Details of Methodology
- Study design and setting The present clinical trial will be conducted in the department of Periodontics, Post Graduate Institute of Dental Sciences, Rohtak, Haryana.
- Study period- up to 24 months
- Study subjects 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.
- 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.
- 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) 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.
m-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 monofilament 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment of RT1 gingival recession defects using m-VISTA with connective tissue graft | Experimental | Procedure: Vestibular incision subperiosteal tunnel access with connective tissue graft in treating RT 1 gingival recession defects |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (10 listed)
- 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 tooth with recession.
- Patients who had already undergone root coverage procedure on the selected site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular incision subperiosteal tunnel access with connective tissue graft in treating RT 1 gingival recession defectsthe 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. | Procedure or surgery | treatment of RT1 gingival recession defects using m-VISTA with connective tissue graft |
Primary outcome
root coverage
Time frame: 6 months
root coverage will be calculated in percentage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tewari contact
Richa Tirkey principal investigator
PGIDS Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular incision subperiosteal tunnel access with connective tissue graft in treating RT 1 gingival recession defects in people with Gingival Recessions, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shikha Tewari, MDS (+919416514600, drshikhatewari@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
root coverage (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.