Gingival RecessionRT1NCT06988839
Effect Of Microneedling With Coronally Advanced Flap For Management of RT1 Gingival Recession In Thin Gingival Phenotype
A study testing Microneedling followed by coronally advanced flap and Coronally advanced flap with connective tissue graft in people with Gingival Recession, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The goal of this clinical trial is to explore the effect of microneedling to increase the gingival tissue thickness which could improve the outcome of root coverage in coronally advanced flap procedure in thin gingival phenotype. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Microneedling followed by coronally advanced flap and Coronally advanced flap with connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 26 Jun 2025to Dec 2026
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of isolated RT1 buccal maxillary gingival recessions in esthetic zone with thin gingival phenotype (Gingival thickness≤1mm) associated with esthetic complaints and/or dental sensitivity and otherwise systemically healthy.
- Gingival Recession ≥2mm , Keratinized tissue width≥2mm and clinically identifiable cementoenamel junction
- Age 20years-50 years
- Patient demonstrating compliance for maintaining good oral hygiene after Phase 1 therapy Plaque index (PI) <1, Gingival Index (GI) <1
- Providing a written and verbal informed consent.
Who cannot join
- Patient with systemic disease that can influence the outcome of therapy.
- Pregnant females or on oral contraceptive pills or hormone replacement therapy.
- Smokers and patients undergoing orthodontic therapy
- Physically and mentally impaired patients.
- Non vital, malpositioned tooth
- Presence of cervical abrasions or restorations in the area
- Previous history of periodontal surgery on the involved sites.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Department of Periodontology, Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
Nishi Tanwar, MDS, +918368126310, nsh_tanwar@yahoo.co.in
Sanjay Tewari, MDS, 01262-297876, principal.pgids@uhsr.ac.in
About this study
Official title: Patient-Centered And Clinical Outcomes Of Microneedling With Coronally Advanced Flap For Management of RT1 Gingival Recession In Thin Gingival Phenotype : A Randomized Controlled Clinical Trial
The goal of this clinical trial is to explore the effect of microneedling to increase the gingival tissue thickness which could improve the outcome of root coverage in coronally advanced flap procedure in thin gingival phenotype. The main question it aims to answer is that :
Does the use of microneedling procedure followed by coronally advanced flap has similar outcomes of root coverage in recession type 1 (RT1) gingival recession i.e. buccal gingival recessions without interdental clinical attachment loss in thin gingival phenotype as compared to coronally advanced flaps with connective tissue graft.
Systemically healthy patients having isolated upper RT1 gingival recession will be assigned into two groups. Microneedling will be performed in one group (4 sessions each at a 10 days interval) followed by coronally advanced flap operation (at an interval of 2 months) and coronally advanced flap with connective tissue graft will be performed in the other group. Follow-up will be done at 1 month, 3 months and 6 months for evaluation of primary and secondary outcomes.
Read the detailed description
The gingival phenotype affects the choice of mucogingival surgical technique for coverage of the root surface in gingival recession. It has been reported that a flap thickness of > 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of < 0.8 mm results in partial root coverage in coronally advanced flap procedure for Miller class I or II root coverage. Thus connective tissue graft (CTG) use is advocated in thin phenotype cases, for improved clinical and esthetic outcomes. Connective tissue graft increases the predictability of coronally advanced flap. Treatment by addition of connective tissue graft has some drawbacks like creation of a second surgical site, postoperative discomfort and long chair side time, leading the researchers to explore techniques less invasive in nature.
Microneedling (MN), also known as "percutaneous collagen induction therapy." It creates microinjuries that result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors, such as platelet-derived growth factors, transforming growth factors, connective tissue growth factor and fibroblast growth factors, are released. In microneedling, the tissue responds as if experiencing minor trauma and the body's own collagen production is induced to preserve skin integrity. Microneedling as opposed to connective tissue grafts is a non-surgical approach to increase gingival thickness, that results in significant changes in the gingival thickness and keratinized tissue width of individuals with thin gingival phenotype. It is associated with higher patient acceptance, lesser surgical site co-morbidities and is a minimally invasive yet an effective approach to augment the gingiva. The histological analysis performed one year post microneedling sessions, showed increased collagen and elastic fiber accumulation in the reticular dermis, a thickened epidermis and a normal stratum corneum, showing its greater effect on gingival thickness.
The present study aims to increase the gingival thickness by microneedling procedures to enhance root coverage by coronally advanced flap procedures in thin gingival phenotype. This technique is proposed to improve thin gingival phenotype by minimally invasive and non-surgical means.
- Conditions
- Gingival Recession
- Being tested
- Microneedling followed by coronally advanced flap, Coronally advanced flap with connective tissue graft
- Keywords
- gingival recession, percutaneous collagen induction, root coverage, connective tissue graft, microneedle
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedling followed by coronally advanced flapProcedure or surgery
Microneedling will be performed using a 30 gauge lancet needles, inserted until hard tissue is felt. It will be performed in 4 sessions at 10 day intervals, followed by coronally advanced flap procedure, 2 months post microneedling.
Coronally advanced flap with connective tissue graftProcedure or surgery
Coronally advanced flap operation will be performed with connective tissue graft harvested from palate after phase 1 therapy.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling with coronally advanced flap | Experimental | In this group, microneedling will be performed using a 30 gauge lancet needles, inserted until hard tissue is felt. It will be performed in 4 sessions at 10 day intervals, followed by coronally advanced flap procedure, 2 months post microneedling. Receives: Procedure: Microneedling followed by coronally advanced flap |
| Coronally advanced flap with connective tissue graft | Active comparator | Coronally advanced flap operation will be performed with connective tissue graft harvested from palate after phase 1 therapy. Receives: Procedure: Coronally advanced flap with connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession depth (RD)
It will be recorded in mm with a periodontal probe from the CEJ to the crest of the gingival margin at the mid-labial region
Measured: Baseline,1,3,6 months
Recession width (RW)
It will be recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.
Measured: Baseline, 1 , 3 and 6 months
Root coverage percentage (RC%)
It will be calculated according to formula Root coverage percentage= RD (preop -postop) *100 /RD preoperative
Measured: Baseline ,1,3 and 6 months
Root Esthetic Score (RES)
The RES system evaluates 5 variables 6 months following surgery: gingival margin, marginal tissue contour (MTC), soft tissue texture (STT), Mucogingival junction alignment, and gingival color (GC). 0, 3, or 6 points will be used for the position of the gingival margin, whereas a score of 0 or 1 point will be used for each of the other variables
Measured: Baseline, 6 months
Patient-centered outcomes
Each patient will be questioned about his/her satisfaction with regard to following criteria: root coverage attained, dentinal hypersensitivity, shape and contour of gums, surgical procedure, and post-surgical phase and it will be assessed using a three-point rating scale.
Measured: Baseline,1,3 and 6 months
Secondary outcomes (5)
Clinical Attachment level (CAL)
Clinical attachment level will be measured as the distance between the CEJ and the base of pocket. Measurements will be made at 6 sites of each tooth using periodontal probe.
Measured: Baseline, 1 , 3 ,6 months
Probing pocket depth
Probing pocket depth will be measured as the distance from gingival margin to the base of pocket. Measurements will be noted at 6 sites of a tooth.
Measured: Baseline,1 ,3 and 6 months
Plaque index
Plaque index will be measured on buccal and lingual surface with Periodontal probe.
Measured: Baseline, 1 ,3 and 6 months
Gingival index
Gingival index will be used to assess severity of gingival inflammation with the help of periodontal probe at 4 sites.
Measured: Baseline,1,3 and 6 months
Gingival thickness
A No:15 endodontic spreader with silicon disc as stopper will be inserted perpendicularly at 1.5mm apical to gingival margin, till the hard tissue will be felt. The depth of penetration will be noted using digital calliper measuring the distance between the tip of the spreader and silicon disc.
Measured: Baeline, 1 ,3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start26 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988839
- Sponsor's protocol ID
- KASHISH PERIO 25/33
- Acronym
- RT1
- Status last verified
- Jun 2026
- First submitted
- 13 May 2025
- Last updated
- 12 Jun 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered And Clinical Outcomes Of Microneedling With Coronally Advanced Flap For Management of RT1 Gingival Recession In Thin Gingival Phenotype : A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06988839
- Acronym / sponsor ID
- RT1 / KASHISH PERIO 25/33
- Conditions
- Gingival Recession
- Keywords
- gingival recession, percutaneous collagen induction, root coverage, connective tissue graft, microneedle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 May 2025 (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.
The goal of this clinical trial is to explore the effect of microneedling to increase the gingival tissue thickness which could improve the outcome of root coverage in coronally advanced flap procedure in thin gingival phenotype. The main question it aims to answer is that :
Does the use of microneedling procedure followed by coronally advanced flap has similar outcomes of root coverage in recession type 1 (RT1) gingival recession i.e. buccal gingival recessions without interdental clinical attachment loss in thin gingival phenotype as compared to coronally advanced flaps with connective tissue graft.
Systemically healthy patients having isolated upper RT1 gingival recession will be assigned into two groups. Microneedling will be performed in one group (4 sessions each at a 10 days interval) followed by coronally advanced flap operation (at an interval of 2 months) and coronally advanced flap with connective tissue graft will be performed in the other group. Follow-up will be done at 1 month, 3 months and 6 months for evaluation of primary and secondary outcomes.
Detailed description
The gingival phenotype affects the choice of mucogingival surgical technique for coverage of the root surface in gingival recession. It has been reported that a flap thickness of > 0.8 mm results in a covered root surface of 100%, whereas a flap thickness of < 0.8 mm results in partial root coverage in coronally advanced flap procedure for Miller class I or II root coverage. Thus connective tissue graft (CTG) use is advocated in thin phenotype cases, for improved clinical and esthetic outcomes. Connective tissue graft increases the predictability of coronally advanced flap. Treatment by addition of connective tissue graft has some drawbacks like creation of a second surgical site, postoperative discomfort and long chair side time, leading the researchers to explore techniques less invasive in nature.
Microneedling (MN), also known as "percutaneous collagen induction therapy." It creates microinjuries that result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors, such as platelet-derived growth factors, transforming growth factors, connective tissue growth factor and fibroblast growth factors, are released. In microneedling, the tissue responds as if experiencing minor trauma and the body's own collagen production is induced to preserve skin integrity. Microneedling as opposed to connective tissue grafts is a non-surgical approach to increase gingival thickness, that results in significant changes in the gingival thickness and keratinized tissue width of individuals with thin gingival phenotype. It is associated with higher patient acceptance, lesser surgical site co-morbidities and is a minimally invasive yet an effective approach to augment the gingiva. The histological analysis performed one year post microneedling sessions, showed increased collagen and elastic fiber accumulation in the reticular dermis, a thickened epidermis and a normal stratum corneum, showing its greater effect on gingival thickness.
The present study aims to increase the gingival thickness by microneedling procedures to enhance root coverage by coronally advanced flap procedures in thin gingival phenotype. This technique is proposed to improve thin gingival phenotype by minimally invasive and non-surgical means.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneedling with coronally advanced flap | Experimental | Procedure: Microneedling followed by coronally advanced flapIn this group, microneedling will be performed using a 30 gauge lancet needles, inserted until hard tissue is felt. It will be performed in 4 sessions at 10 day intervals, followed by coronally advanced flap procedure, 2 months post microneedling. |
| Coronally advanced flap with connective tissue graft | Active comparator | Procedure: Coronally advanced flap with connective tissue graftCoronally advanced flap operation will be performed with connective tissue graft harvested from palate after phase 1 therapy. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Presence of isolated RT1 buccal maxillary gingival recessions in esthetic zone with thin gingival phenotype (Gingival thickness≤1mm) associated with esthetic complaints and/or dental sensitivity and otherwise systemically healthy.
- Gingival Recession ≥2mm , Keratinized tissue width≥2mm and clinically identifiable cementoenamel junction
- Age 20years-50 years
- Patient demonstrating compliance for maintaining good oral hygiene after Phase 1 therapy Plaque index (PI) <1, Gingival Index (GI) <1
- Providing a written and verbal informed consent.
Key exclusion criteria (7 listed)
- Patient with systemic disease that can influence the outcome of therapy.
- Pregnant females or on oral contraceptive pills or hormone replacement therapy.
- Smokers and patients undergoing orthodontic therapy
- Physically and mentally impaired patients.
- Non vital, malpositioned tooth
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 |
|---|---|---|
| Microneedling followed by coronally advanced flapMicroneedling will be performed using a 30 gauge lancet needles, inserted until hard tissue is felt. It will be performed in 4 sessions at 10 day intervals, followed by coronally advanced flap procedure, 2 months post microneedling. | Procedure or surgery | Microneedling with coronally advanced flap |
| Coronally advanced flap with connective tissue graftCoronally advanced flap operation will be performed with connective tissue graft harvested from palate after phase 1 therapy. | Procedure or surgery | Coronally advanced flap with connective tissue graft |
Primary outcome
Recession depth (RD)
Time frame: Baseline,1,3,6 months
It will be recorded in mm with a periodontal probe from the CEJ to the crest of the gingival margin at the mid-labial region
Recession width (RW)
Time frame: Baseline, 1 , 3 and 6 months
It will be recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.
Root coverage percentage (RC%)
Time frame: Baseline ,1,3 and 6 months
It will be calculated according to formula Root coverage percentage= RD (preop -postop) *100 /RD preoperative
Root Esthetic Score (RES)
Time frame: Baseline, 6 months
The RES system evaluates 5 variables 6 months following surgery: gingival margin, marginal tissue contour (MTC), soft tissue texture (STT), Mucogingival junction alignment, and gingival color (GC). 0, 3, or 6 points will be used for the position of the gingival margin, whereas a score of 0 or 1 point will be used for each of the other variables
Patient-centered outcomes
Time frame: Baseline,1,3 and 6 months
Each patient will be questioned about his/her satisfaction with regard to following criteria: root coverage attained, dentinal hypersensitivity, shape and contour of gums, surgical procedure, and post-surgical phase and it will be assessed using a three-point rating scale.
5 secondary outcomes
Clinical Attachment level (CAL)
Time frame: Baseline, 1 , 3 ,6 months
Probing pocket depth
Time frame: Baseline,1 ,3 and 6 months
Plaque index
Time frame: Baseline, 1 ,3 and 6 months
Gingival index
Time frame: Baseline,1,3 and 6 months
Gingival thickness
Time frame: Baeline, 1 ,3 and 6 months
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 12 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling followed by coronally advanced flap and Coronally advanced flap with connective tissue graft in people with Gingival Recession, 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 5 inclusion and 7 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 12 Jun 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 Nishi Tanwar, MDS (8368126310, nsh_tanwar@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recession depth (RD) (time frame: Baseline,1,3,6 months). The study lists 5 primary outcomes in all. 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 12 Jun 2026.