Gingival PhenotypePhase 2NCT06060119
Comparison of Microneedling and CTG for Gingival Augmentation- A RCT
A Phase 2 study testing microneedling in people with Gingival Phenotype, run by Krishnadevaraya College of Dental Sciences & Hospital.
Trial summary
The presence study is toComparison of Microneedling with Subepithelial Connective Tissue Auto Graft for Gingival Augmentation- A Randomized Case Control Trial. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Phenotype
- What is being tested?
- microneedling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2023to 30 Jul 2024
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients > 18 years of age.
- Patients with esthetic concern .
- Patient under going orthodontic, prosthodontic, restorative treatment where thick gingiva is necessary.
- Systemically healthy subjects
- Full mouth plaque index,full mouth bleeding on probing score < or = 15
- Patient with palatal mucosa greater than 4mm
Who cannot join
- Previous periodontal surgery
- Patients with history of coagulation disorder
- Smoking habit
- Pregnant and lactating females
- Use of any
Trial locations and contacts
No sites are listed yet.
rashmi p, MDS contact
About this study
Official title: Comparison of Microneedling With Subepithelial Connective Tissue Auto Graft for Gingival Augmentation- A Randomized Case Control Trial
The presence study is toComparison of Microneedling with Subepithelial Connective Tissue Auto Graft for Gingival Augmentation- A Randomized Case Control Trial. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
Read the detailed description
The periodontal phenotype previously called as biotype is a reflection of gingiva and buccal bone thickness. It is a vital clinical parameter as it will determine whether there will be recession , dehiscence and fenestration or pocket formation.1Basically gingival epithelium provides a physical barrier to infection and protects the deeper structures thus, the gingival phenotype has major impact on the outcome of the restorative, regenerative, implant and orthodontic therapy.2 Common causes of recession are faulty toothbrushing ,tooth malposition, abnormal frenum attachment, trauma from occlusion and orthodontic tooth movement in labial direction.2 Gingiva can be classified as thick > 1mm and thin < 1mm according to recent 2017 world work shop classification.3 Traditionally, gingival augmentation is achieved using free gingival graft, connective tissue graft, soft tissue substitutes. Subepithelial connective tissue auto graft is still the gold standard. All of these technique's are invasive, complicated, technique senstive and do not have cost efficiency4, thus there is an on going reasearch for a more simpler non invasive method to increase gingival thickness.
Microneedling also knows as "percutaneous collagen induction therapy" is a novel and innovative method to thicken gingiva.5It involves creating several microinjuries in the form of inducing superficial bleeding points there by inducing a wound healing cascade which releases a few key soft tissue growth factor's such as platelet-derived growth factors, transforming growth factors, connective tissue growth factor and fibroblast growth factors.1 Fernandes has developed a percutaneous technology based on principals of microneedling to initiate natural post traumatic inflammatory reaction by using microneedles.6 The growthfactor's thus released post injury stimulate proliferation of new cells and transformation of fibroblast into collagen and elastin fiber, starting from 5th day up to 8th week. Newly formed fibers thicken the tissue during the process known as neocollagenesis. Fibroblasts also trigger neoangiogenesis by accelerating the proliferation of endothelial cells in the blood vessels. The tissue remodeling changes continue from 8 weeks up to 1 year.7 Thus, this non-invasive technique of microneedling will be compared to the time tested subepithelial connective tissue autograft to obtain a deeper insight over its feasibility.
- Conditions
- Gingival Phenotype
- Being tested
- microneedling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microneedlingDevice
Also called Derma pen
The operative sites will be anaesthetized with 2% lignocaine hydrochloride with adrenaline(1:80,000).Electric microneedling pen device model THAPPINKTM is used. Microneedling is carried out on the isolated site involving one tooth mesially and distally and 1.5mm apical to marginal gingiva each for 30-40 second intermittently. When pin point bleeding observed on the area of gingiva it is irrigated with sterile saline solution. Patient will be instructed to refrain from consuming hot beverage and brushing in that area for one day to avoid mechanical trauma. A total of 4 session of micro needling procedure will be carried out in one subject at 10 days intervals upto 40days
| Study group | Role | What they receive |
|---|---|---|
| Comparison of Microneedling for Gingival Augmentation- A Randomized Case Control Trial | Experimental | 1. TEST GROUP (n = 12) - Microneedling on the selected a non-steroidal anti-inflammatory drug (Tab Ibuprofen 400mg) and antibiotic Amoxicillin 500mg thrice daily for three days after meals will be prescribed. In patients allergic to Amoxicillin, Clindamycin 300mg thrice daily is prescribed13 Receives: Device: microneedling |
| Comparison of Microneedling with for Gingival Augmentation- A Randomized Case Control Trial | Experimental | 2.CONTROL GROUP (n = 12) - Subepithelial connective tissue grafting at the contralateral site non-steroidal anti-inflammatory drug (Tab Ibuprofen 400mg) and antibiotic Amoxicillin 500mg thrice daily for three days after meals will be prescribed. In patients allergic to Amoxicillin, Clindamycin 300mg thrice daily is prescribed13 Receives: Device: microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
OBJECTIVES OF THE STUDY: The primary outcomes measured will be : 1) Increase in gingival augmentation with microneedling
- Increase in gingival augmentation with microneedling will be measured in (mm)
- Comparison of microneedling with subepithelial connective tissue graft for gingival thickness in(mm) digital calliper and spreader file
Measured: 6 months
Secondary outcomes (1)
thickness in mm
Increase KTW (keratinization tissue width) will be checked in digital calliper and spreader file
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 Sep 2023
- Study start28 Nov 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival PhenotypeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SAMPLING TECHNIQUE Purposive Sampling technique will be done. All the patients meeting the criteria will be screened and then 12 patients will be randomly allotted into either of the two groups. The treatment allocation to the test and control group will be assigned by means of a sealed envelope containing a code derived from a computer generated randomized list to receive either - 1. TEST GROUP (n = 12) - Microneedling on the selected area. 2. CONTROL GROUP (n = 12) - Subepithelial connective tissue grafting at the contralateral site
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060119
- Sponsor's protocol ID
- KCDSHEC/IP/2022/S21
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Microneedling With Subepithelial Connective Tissue Auto Graft for Gingival Augmentation- A Randomized Case Control Trial
- ClinicalTrials.gov ID
- NCT06060119
- Acronym / sponsor ID
- KCDSHEC/IP/2022/S21
- Conditions
- Gingival Phenotype
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 28 Nov 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 29 Sep 2023 (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 presence study is toComparison of Microneedling with Subepithelial Connective Tissue Auto Graft for Gingival Augmentation- A Randomized Case Control Trial. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
Detailed description
The periodontal phenotype previously called as biotype is a reflection of gingiva and buccal bone thickness. It is a vital clinical parameter as it will determine whether there will be recession , dehiscence and fenestration or pocket formation.1Basically gingival epithelium provides a physical barrier to infection and protects the deeper structures thus, the gingival phenotype has major impact on the outcome of the restorative, regenerative, implant and orthodontic therapy.2 Common causes of recession are faulty toothbrushing ,tooth malposition, abnormal frenum attachment, trauma from occlusion and orthodontic tooth movement in labial direction.2 Gingiva can be classified as thick > 1mm and thin < 1mm according to recent 2017 world work shop classification.3 Traditionally, gingival augmentation is achieved using free gingival graft, connective tissue graft, soft tissue substitutes. Subepithelial connective tissue auto graft is still the gold standard. All of these technique's are invasive, complicated, technique senstive and do not have cost efficiency4, thus there is an on going reasearch for a more simpler non invasive method to increase gingival thickness.
Microneedling also knows as "percutaneous collagen induction therapy" is a novel and innovative method to thicken gingiva.5It involves creating several microinjuries in the form of inducing superficial bleeding points there by inducing a wound healing cascade which releases a few key soft tissue growth factor's such as platelet-derived growth factors, transforming growth factors, connective tissue growth factor and fibroblast growth factors.1 Fernandes has developed a percutaneous technology based on principals of microneedling to initiate natural post traumatic inflammatory reaction by using microneedles.6 The growthfactor's thus released post injury stimulate proliferation of new cells and transformation of fibroblast into collagen and elastin fiber, starting from 5th day up to 8th week. Newly formed fibers thicken the tissue during the process known as neocollagenesis. Fibroblasts also trigger neoangiogenesis by accelerating the proliferation of endothelial cells in the blood vessels. The tissue remodeling changes continue from 8 weeks up to 1 year.7 Thus, this non-invasive technique of microneedling will be compared to the time tested subepithelial connective tissue autograft to obtain a deeper insight over its feasibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- SAMPLING TECHNIQUE Purposive Sampling technique will be done. All the patients meeting the criteria will be screened and then 12 patients will be randomly allotted into either of the two groups. The treatment allocation to the test and control group will be assigned by means of a sealed envelope containing a code derived from a computer generated randomized list to receive either - 1. TEST GROUP (n = 12) - Microneedling on the selected area. 2. CONTROL GROUP (n = 12) - Subepithelial connective tissue grafting at the contralateral site
| Arm | Type | Receives |
|---|---|---|
| Comparison of Microneedling for Gingival Augmentation- A Randomized Case Control Trial | Experimental | Device: microneedling1. TEST GROUP (n = 12) - Microneedling on the selected a non-steroidal anti-inflammatory drug (Tab Ibuprofen 400mg) and antibiotic Amoxicillin 500mg thrice daily for three days after meals will be prescribed. In patients allergic to Amoxicillin, Clindamycin 300mg thrice daily is prescribed13 |
| Comparison of Microneedling with for Gingival Augmentation- A Randomized Case Control Trial | Experimental | Device: microneedling2.CONTROL GROUP (n = 12) - Subepithelial connective tissue grafting at the contralateral site non-steroidal anti-inflammatory drug (Tab Ibuprofen 400mg) and antibiotic Amoxicillin 500mg thrice daily for three days after meals will be prescribed. In patients allergic to Amoxicillin, Clindamycin 300mg thrice daily is prescribed13 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients > 18 years of age.
- Patients with esthetic concern .
- Patient under going orthodontic, prosthodontic, restorative treatment where thick gingiva is necessary.
- Systemically healthy subjects
- Full mouth plaque index,full mouth bleeding on probing score < or = 15
Key exclusion criteria (5 listed)
- Previous periodontal surgery
- Patients with history of coagulation disorder
- Smoking habit
- Pregnant and lactating females
- Use of any
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 |
|---|---|---|
| microneedlingAlso: Derma penThe operative sites will be anaesthetized with 2% lignocaine hydrochloride with adrenaline(1:80,000).Electric microneedling pen device model THAPPINKTM is used. Microneedling is carried out on the isolated site involving one tooth mesially and distally and 1.5mm apical to marginal gingiva each for 30-40 second intermittently. When pin point bleeding observed on the area of gingiva it is irrigated with sterile saline solution. Patient will be instructed to refrain from consuming hot beverage and brushing in that area for one day to avoid mechanical trauma. A total of 4 session of micro needling procedure will be carried out in one subject at 10 days intervals upto 40days | Device | Comparison of Microneedling for Gingival Augmentation- A Randomized Case Control Trial, Comparison of Microneedling with for Gingival Augmentation- A Randomized Case Control Trial |
Primary outcome
OBJECTIVES OF THE STUDY: The primary outcomes measured will be : 1) Increase in gingival augmentation with microneedling
Time frame: 6 months
1. Increase in gingival augmentation with microneedling will be measured in (mm) 2. Comparison of microneedling with subepithelial connective tissue graft for gingival thickness in(mm) digital calliper and spreader file
1 secondary outcome
thickness in mm
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- 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. This study is not recruiting at the moment.
rashmi p, MDS contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing microneedling in people with Gingival Phenotype, run by Krishnadevaraya College of Dental Sciences & Hospital.
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 5 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANUSHA S, MDS (7204759280, sanusha097@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OBJECTIVES OF THE STUDY: The primary outcomes measured will be : 1) Increase in gingival augmentation with microneedling (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 29 Sep 2023.