Gingival Recession, LocalizedNCT06432439
Impact of Microneedling on Coverage of RT1 Gingival Recession in Thin Phenotype.
A study testing microneedling followed by CAF procedures and CAF procedure in people with Gingival Recession, Localized, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Gingival Recession (GR) is a common finding among adults, regardless of the oral hygiene levels. When it is associated with esthetic impairment, dentin hypersensitivity, root caries, surgical treatment is indicated. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized
- What is being tested?
- microneedling followed by CAF procedures and CAF procedure
- 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
- 1 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of isolated Recession Type 1 buccal maxillary gingival recessions in esthetic zone including maxillary central incisors, lateral incisors and canines associated with esthetic complaints and/or dental sensitivity and otherwise systemically healthy.
- Gingival Recession ≥2mm and clinically identifiable CEJ
- 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.
India1 site
post graduate institute of dental sciences (PGIDS)
Rohtak, Haryana, 124001
About this study
Official title: Microneedling And Its Effect On Outcome Of Root Coverage With Coronally Advanced Flap Involving Isolated RT1 Maxillary Gingival Recession In Thin Gingival Phenotype: A Randomized Controlled Clinical Trial
Gingival Recession (GR) is a common finding among adults, regardless of the oral hygiene levels. When it is associated with esthetic impairment, dentin hypersensitivity, root caries, surgical treatment is indicated. Mid-buccal Gingival Recessions are an extremely prevalent condition and have root coverage potential through periodontal plastic surgery procedures.
A flap thickness of > 0.8 mm results in 100% root coverage, whereas a flap thickness of < 0.8 mm results in partial root coverage in Coronally Advanced Flap (CAF)procedure.
The present study aims to increase the gingival thickness by microneedling procedures to enhance root coverage by CAF procedures in thin gingival phenotype.
Read the detailed description
Gingival recession (GR) is defined as the migration of the marginal tissue toward the apical of the cementoenamel junction. It is one of the most common mucogingival deformities requiring surgical correction. The rationale for treating buccal recessions are mainly aesthetic concerns, and clinical situations where unfavourable contour of the gingival margin might be an obstacle for proper plaque control. GRs are of 3 types with reference to interdental clinical attachment loss as Recession Type (RT) RT1, RT2 and RT3. Mid-buccal GRs have root coverage potential through periodontal plastic surgery procedures. Coronally positioned flap (CAF) is a simple and predictable treatment of gingival recession defects. It has been observed 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 CAF procedure. Microneedling (MN), creates microinjuries that result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors are released. MN as opposed to Connective Tissue Grafts is a non-surgical approach to increase gingival thickness, that results in significant changes in the Gingival Thickness of individuals with thin gingival phenotype.
- Conditions
- Gingival Recession, Localized
- Being tested
- microneedling followed by CAF procedures, CAF procedure
- Keywords
- microneedling, phenotype, gingival recession, coronally advanced flap
- 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 CAF proceduresProcedure or surgery
Isolated RT1 gingival recession treated by microneedling followed by Coronally Advanced Flap procedures
CAF procedureProcedure or surgery
Isolated RT1 gingival recession treated by Coronally Advanced Flap procedures alone.
| Study group | Role | What they receive |
|---|---|---|
| TEST GROUP | Experimental | Isolated RT1 gingival recession treated by microneedling followed by Coronally Advanced Flap procedures Receives: Procedure: microneedling followed by CAF procedures |
| CONTROL GROUP | Active comparator | Isolated RT1 gingival recession treated by Coronally Advanced Flap procedures alone. Receives: Procedure: CAF procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession Depth
recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at mid labial region.
Measured: 6 months
RECESSION WIDTH (RW)
recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.
Measured: 6 months
ROOT COVERAGE PERCENTAGE
calculated in % according to the formula Root Coverage percentage = Recession depth (preop-postop)*100 Recession depth preoperative
Measured: 6 months
Gingival thickness(GT)
GT is calculated in mm and measured with the help of No:15 endodontic spreaders with silicon disc as stopper was inserted perpendicularly at 1.5mm apical to gingival margin, till the hard tissue was felt. The depth of penetration was noted using digital calliper
Measured: 6 months
Secondary outcomes (6)
CLINICAL ATTACHMENT LEVEL (CAL)
Clinical attachment level will be measured in mm using a periodontal probe as the distance between the cemento- enamel junction and the base of pocket. Measurements will be made at 3 sites of each tooth
Measured: 6 months
Probing Pocket Depth (PPD)
Probing pocket depth will be measured as the distance from gingival margin to the base of pocket in mm. The probing depth measurements will be assessed using the Periodontal probe
Measured: 6 months
Bleeding on Probing (BOP)
It will be measured by walking the periodontal probe at each site of each tooth and recorded as 0 or 1.
Measured: 6 months
Plaque Index (PI)
For the scoring, a mouth mirror, an explorer and a light source will be used on air dried teeth and gingiva. 0=no plaque, 1= plaque present on explorer and not visible to naked eye, 2= moderate layer of plaque visible to naked eye, 3= abundant plaque along gingival margin. Lesser score, better outcome.
Measured: 6 months
Gingival Index (GI
Gingival index (GI) will be used to assess severity of gingival inflammation. 0= no inflammation, 1= mild inflammation, no bleeding. 2= inflammation with delayed bleeding. 3= spontaneous bleeding. lower score, better outcome.
Measured: 6 months
Keratinized Tissue Width (KTW)
Keratinized tissue width will be measured in mm with the help of UNC 15 probe with silicon stopper from the mucogingival junction to the free gingival margin and measured on vernier caliper
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 posted29 May 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession, LocalizedStudies 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
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amisha Goyal, BDS, Principal investigator, PGIDS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432439
- Sponsor's protocol ID
- Amisha perio
- Status last verified
- May 2026
- First submitted
- 22 May 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling And Its Effect On Outcome Of Root Coverage With Coronally Advanced Flap Involving Isolated RT1 Maxillary Gingival Recession In Thin Gingival Phenotype: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06432439
- Acronym / sponsor ID
- Amisha perio
- Conditions
- Gingival Recession, Localized
- Keywords
- microneedling, phenotype, gingival recession, coronally advanced flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 29 May 2024 (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.
Gingival Recession (GR) is a common finding among adults, regardless of the oral hygiene levels. When it is associated with esthetic impairment, dentin hypersensitivity, root caries, surgical treatment is indicated. Mid-buccal Gingival Recessions are an extremely prevalent condition and have root coverage potential through periodontal plastic surgery procedures.
A flap thickness of > 0.8 mm results in 100% root coverage, whereas a flap thickness of < 0.8 mm results in partial root coverage in Coronally Advanced Flap (CAF)procedure.
The present study aims to increase the gingival thickness by microneedling procedures to enhance root coverage by CAF procedures in thin gingival phenotype.
Detailed description
Gingival recession (GR) is defined as the migration of the marginal tissue toward the apical of the cementoenamel junction. It is one of the most common mucogingival deformities requiring surgical correction. The rationale for treating buccal recessions are mainly aesthetic concerns, and clinical situations where unfavourable contour of the gingival margin might be an obstacle for proper plaque control. GRs are of 3 types with reference to interdental clinical attachment loss as Recession Type (RT) RT1, RT2 and RT3. Mid-buccal GRs have root coverage potential through periodontal plastic surgery procedures. Coronally positioned flap (CAF) is a simple and predictable treatment of gingival recession defects. It has been observed 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 CAF procedure. Microneedling (MN), creates microinjuries that result in minimal superficial bleedings and create a wound-healing cascade from which various growth factors are released. MN as opposed to Connective Tissue Grafts is a non-surgical approach to increase gingival thickness, that results in significant changes in the Gingival Thickness of individuals with thin gingival phenotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST GROUP | Experimental | Procedure: microneedling followed by CAF proceduresIsolated RT1 gingival recession treated by microneedling followed by Coronally Advanced Flap procedures |
| CONTROL GROUP | Active comparator | Procedure: CAF procedureIsolated RT1 gingival recession treated by Coronally Advanced Flap procedures alone. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Presence of isolated Recession Type 1 buccal maxillary gingival recessions in esthetic zone including maxillary central incisors, lateral incisors and canines associated with esthetic complaints and/or dental sensitivity and otherwise systemically healthy.
- Gingival Recession ≥2mm and clinically identifiable CEJ
- 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 CAF proceduresIsolated RT1 gingival recession treated by microneedling followed by Coronally Advanced Flap procedures | Procedure or surgery | TEST GROUP |
| CAF procedureIsolated RT1 gingival recession treated by Coronally Advanced Flap procedures alone. | Procedure or surgery | CONTROL GROUP |
Primary outcome
Recession Depth
Time frame: 6 months
recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at mid labial region.
RECESSION WIDTH (RW)
Time frame: 6 months
recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.
ROOT COVERAGE PERCENTAGE
Time frame: 6 months
calculated in % according to the formula Root Coverage percentage = Recession depth (preop-postop)*100 Recession depth preoperative
Gingival thickness(GT)
Time frame: 6 months
GT is calculated in mm and measured with the help of No:15 endodontic spreaders with silicon disc as stopper was inserted perpendicularly at 1.5mm apical to gingival margin, till the hard tissue was felt. The depth of penetration was noted using digital calliper
6 secondary outcomes
CLINICAL ATTACHMENT LEVEL (CAL)
Time frame: 6 months
Probing Pocket Depth (PPD)
Time frame: 6 months
Bleeding on Probing (BOP)
Time frame: 6 months
Plaque Index (PI)
Time frame: 6 months
Gingival Index (GI
Time frame: 6 months
Keratinized Tissue Width (KTW)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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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. This study is not recruiting at the moment.
Amisha Goyal, BDS principal investigator
PGIDS
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 CAF procedures and CAF procedure in people with Gingival Recession, Localized, 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: finished, as of the sponsor's last update on 7 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recession Depth (time frame: 6 months). The study lists 4 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 7 May 2026.