Thin-gingivaNCT05869136
Evaluation Of Microneedling Alone vs Microneedling Along With Hyaluronic Acid In Thin Gingival Phenotype
A study testing microneedling and hyaluronic acid for increasing gingival thickness in thin gingival phenotype and microneedling for increasing gingival thickness in thin gingival phenotype in people with Thin-gingiva, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The periodontal phenotype has been defined as the combination of gingival phenotype and buccal bone plate thickness (bone morphotype).Periodontal phenotype cannot be fully assessed but gingival phenotype can be evaluated through a standard and reproducible way. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Thin-gingiva
- What is being tested?
- microneedling and hyaluronic acid for increasing gingival thickness in thin gingival phenotype and microneedling for increasing gingival thickness in thin gingival phenotype
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 16 Oct 2023to Apr 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Thin gingival phenotype with gingival tissue thickness <1mm in mandibular anteriors
- All the patients will be subjected to phase-I therapy and will be included after achieving healthy gingiva with Plaque index (Silness \& Loe) <1, gingival index (Loe \& Silness) <1 and showing adequate compliance and willing to participate in the study.
Who cannot join
- Patients having systemic diseases such as hypertension, diabetes, hyperthyroidism or on medications that influence the outcome of periodontal procedure
- Smokers, tobacco users
- Previous periodontal surgery
- No haematological disorders.
- Use of blood thinners
- Use of any drugs that might lead to gingival enlargement
- Stress, bruxism
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
About this study
Official title: Comparative Evaluation Of Microneedling Alone vs Microneedling Along With Hyaluronic Acid In Thin Gingival Phenotype: A Split Mouth Randomized Clinical Trial
The periodontal phenotype has been defined as the combination of gingival phenotype and buccal bone plate thickness (bone morphotype).Periodontal phenotype cannot be fully assessed but gingival phenotype can be evaluated through a standard and reproducible way.
Gingival recession is usually observed in the presence of trauma and inflammation in individuals with thin phenotypes, whereas pocket formation has been reported in individuals with thick phenotypes.
Read more
Various soft tissue augmentation procedures include: sub-epithelial connective tissue graft, free gingival graft, modified roll technique and use of acellular dermal matrix. The drawbacks of these techniques include second surgical site creation, post-operative discomfort, time consuming procedure, etc.
Recent studies have shown i-PRF, microneedeling and hyaluronic acid procedures to be effective in increasing gingival tissue thickness.
HA has been widely used in the dental field, specially periodontology, due to its bacteriostatic, fungistatic, anti-inflammatory, anti-edematous, osteoinductive, and pro-angiogenetic properties. HA's role in tissue regeneration and wound healing has gained huge interest in recent studies.
Microneedling (MN) is also known as "percutaneous collagen induction therapy." Microinjuries created by MN 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.Study has shown a statistically significant increase in gingival thickness when microneedling was performed along with i-PRF in comparison to standalone i-PRF.
Few human trials have been conducted using MN and Hyaluronic acids in literature for gingival augmentation in thin periodontal phenotype. Considering the effects of MN and hyaluronic acid on the biological potential, neoangiogenesis, neocollagenesis and wound, the present Randomized clinical trial is designed to evaluate the effects of MN alone and MN along with hyaluronic acid in thin gingival phenotype.
Read the detailed description
Gingival phenotype refers to gingival thickness (GT) and keratinized tissue width (KTW).
Gingival phenotypes can be classified as scalloped and thin or flat and thick gingiva. Thin gingival phenotype are very friable and might be prone to recede in response to traumatic insults, such as plaque-related inflammation and traumatic toothbrushing .Studies have believed that HA accelerates the wound healing process, and promotes regeneration, as it maintains the viability of oral fibroblasts, increases their proliferative and migratory abilities, and enhances the expression of genes encoding type III collagen and transforming growth factor-β. Study has shown a statistically significant increase in gingival thickness when microneedling was performed along with i-PRF in comparison to standalone i-PRF.
Given these characteristics,this study will be conducted to comparative evaluation of microneedling alone and along with hyaluronic acid on thin gingival phenotype.
The present randomized controlled clinical trial will be conducted in the department of periodontics and oral implantology,Post Graduate Institute of Dental Sciences,Rohtak.Study design is of 24 months.
Total 20 patients will be recruited on the basis of inclusion and exclusion criteria with thin periodontal phenotypes who had consulted to the Department of Periodontology, Post Graduate Institute of Dental Sciences, Rohtak.
20 systematically healthy patients having thin gingival phenotypes will be included in this split-mouth randomized controlled trial. For each patient, each side of the anterior mandible will be randomly allocated to one of the two procedures (MN or MN with Hyaluronic acid)using chit system. In the MN group microneedling will be done 1 mm below the gingival margin with 30-gauze lancet needles. In the HA with MN group, the selected sites of the gingiva will injected with cross-linked HA using a 30-gauge microneedle followed by microneedling. This described procedure will be repeated in both groups three times with intervals of 10 days. The GT, KTW, and periodontal indices: gingival index (GI), bleeding on probing (BOP), and probing depth (PD) will be measured at baseline, 1 month, 6 months and 9 months.
- Conditions
- Thin-gingiva
- Being tested
- microneedling and hyaluronic acid for increasing gingival thickness in thin gingival phenotype, microneedling for increasing gingival thickness in thin gingival phenotype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microneedling and hyaluronic acid for increasing gingival thickness in thin gingival phenotypeProcedure or surgery
All the participants will undergo phase-I therapy. Oral hygiene instructions will be imparted and will be reinforced at each appointment.
Local anaesthesia in the form of xylocaine spray will be administered.
Hyaluronic acid:
HA will be injected in the attached gingiva and MN will be carried out 1mm below the gingival margin on the keratinized gingiva of the tooth to be treated with thirty-gauge (0.255 mm) lancet needles in the test group.
microneedling for increasing gingival thickness in thin gingival phenotypeProcedure or surgery
All the participants will undergo phase-I therapy. Oral hygiene instructions will be imparted and will be reinforced at each appointment.
Local anaesthesia in the form of xylocaine spray will be administered and microneedling alone will be performed in control group
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Microneedling along with hyaluronic acid in thin gingival phenotype Receives: Procedure: microneedling and hyaluronic acid for increasing gingival thickness in thin gingival phenotype |
| Control group | Active comparator | Microneedling in thin gingival phenotype Receives: Procedure: microneedling for increasing gingival thickness in thin gingival phenotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of gingival thickness (GT)
To measure GT from the apical 1.5 mm of the gingival margin, a No:15 endodontic spreader with a 3-mm-diameter silicone disc will be placed in the centre and will be measured on Vernier caliper.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start16 Oct 2023
- Primary completionDec 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thin-gingivaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Nishi Tanwar, MDS, Principal investigator, Post graduate institute of dental sciences,Rohtak,Haryana,India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869136
- Sponsor's protocol ID
- Nishi Tanwar
- Status last verified
- Feb 2024
- First submitted
- 11 May 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation Of Microneedling Alone vs Microneedling Along With Hyaluronic Acid In Thin Gingival Phenotype: A Split Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05869136
- Acronym / sponsor ID
- Nishi Tanwar
- Conditions
- Thin-gingiva
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 22 May 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 periodontal phenotype has been defined as the combination of gingival phenotype and buccal bone plate thickness (bone morphotype).Periodontal phenotype cannot be fully assessed but gingival phenotype can be evaluated through a standard and reproducible way.
Gingival recession is usually observed in the presence of trauma and inflammation in individuals with thin phenotypes, whereas pocket formation has been reported in individuals with thick phenotypes.
Various soft tissue augmentation procedures include: sub-epithelial connective tissue graft, free gingival graft, modified roll technique and use of acellular dermal matrix. The drawbacks of these techniques include second surgical site creation, post-operative discomfort, time consuming procedure, etc.
Recent studies have shown i-PRF, microneedeling and hyaluronic acid procedures to be effective in increasing gingival tissue thickness.
HA has been widely used in the dental field, specially periodontology, due to its bacteriostatic, fungistatic, anti-inflammatory, anti-edematous, osteoinductive, and pro-angiogenetic properties. HA's role in tissue regeneration and wound healing has gained huge interest in recent studies.
Microneedling (MN) is also known as "percutaneous collagen induction therapy." Microinjuries created by MN 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.Study has shown a statistically significant increase in gingival thickness when microneedling was performed along with i-PRF in comparison to standalone i-PRF.
Few human trials have been conducted using MN and Hyaluronic acids in literature for gingival augmentation in thin periodontal phenotype. Considering the effects of MN and hyaluronic acid on the biological potential, neoangiogenesis, neocollagenesis and wound, the present Randomized clinical trial is designed to evaluate the effects of MN alone and MN along with hyaluronic acid in thin gingival phenotype.
Detailed description
Gingival phenotype refers to gingival thickness (GT) and keratinized tissue width (KTW).
Gingival phenotypes can be classified as scalloped and thin or flat and thick gingiva. Thin gingival phenotype are very friable and might be prone to recede in response to traumatic insults, such as plaque-related inflammation and traumatic toothbrushing .Studies have believed that HA accelerates the wound healing process, and promotes regeneration, as it maintains the viability of oral fibroblasts, increases their proliferative and migratory abilities, and enhances the expression of genes encoding type III collagen and transforming growth factor-β. Study has shown a statistically significant increase in gingival thickness when microneedling was performed along with i-PRF in comparison to standalone i-PRF.
Given these characteristics,this study will be conducted to comparative evaluation of microneedling alone and along with hyaluronic acid on thin gingival phenotype.
The present randomized controlled clinical trial will be conducted in the department of periodontics and oral implantology,Post Graduate Institute of Dental Sciences,Rohtak.Study design is of 24 months.
Total 20 patients will be recruited on the basis of inclusion and exclusion criteria with thin periodontal phenotypes who had consulted to the Department of Periodontology, Post Graduate Institute of Dental Sciences, Rohtak.
20 systematically healthy patients having thin gingival phenotypes will be included in this split-mouth randomized controlled trial. For each patient, each side of the anterior mandible will be randomly allocated to one of the two procedures (MN or MN with Hyaluronic acid)using chit system. In the MN group microneedling will be done 1 mm below the gingival margin with 30-gauze lancet needles. In the HA with MN group, the selected sites of the gingiva will injected with cross-linked HA using a 30-gauge microneedle followed by microneedling. This described procedure will be repeated in both groups three times with intervals of 10 days. The GT, KTW, and periodontal indices: gingival index (GI), bleeding on probing (BOP), and probing depth (PD) will be measured at baseline, 1 month, 6 months and 9 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: microneedling and hyaluronic acid for increasing gingival thickness in thin gingival phenotypeMicroneedling along with hyaluronic acid in thin gingival phenotype |
| Control group | Active comparator | Procedure: microneedling for increasing gingival thickness in thin gingival phenotypeMicroneedling in thin gingival phenotype |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Thin gingival phenotype with gingival tissue thickness <1mm in mandibular anteriors
- All the patients will be subjected to phase-I therapy and will be included after achieving healthy gingiva with Plaque index (Silness \& Loe) <1, gingival index (Loe \& Silness) <1 and showing adequate compliance and willing to participate in the study.
Key exclusion criteria (7 listed)
- Patients having systemic diseases such as hypertension, diabetes, hyperthyroidism or on medications that influence the outcome of periodontal procedure
- Smokers, tobacco users
- Previous periodontal surgery
- No haematological disorders.
- Use of blood thinners
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 and hyaluronic acid for increasing gingival thickness in thin gingival phenotypeAll the participants will undergo phase-I therapy. Oral hygiene instructions will be imparted and will be reinforced at each appointment. Local anaesthesia in the form of xylocaine spray will be administered. Hyaluronic acid: HA will be injected in the attached gingiva and MN will be carried out 1mm below the gingival margin on the keratinized gingiva of the tooth to be treated with thirty-gauge (0.255 mm) lancet needles in the test group. | Procedure or surgery | Test group |
| microneedling for increasing gingival thickness in thin gingival phenotypeAll the participants will undergo phase-I therapy. Oral hygiene instructions will be imparted and will be reinforced at each appointment. Local anaesthesia in the form of xylocaine spray will be administered and microneedling alone will be performed in control group | Procedure or surgery | Control group |
Primary outcome
Measurement of gingival thickness (GT)
Time frame: 9 months
To measure GT from the apical 1.5 mm of the gingival margin, a No:15 endodontic spreader with a 3-mm-diameter silicone disc will be placed in the centre and will be measured on Vernier caliper.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
Dr Nishi Tanwar, MDS principal investigator
Post graduate institute of dental sciences,Rohtak,Haryana,India
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 and hyaluronic acid for increasing gingival thickness in thin gingival phenotype and microneedling for increasing gingival thickness in thin gingival phenotype in people with Thin-gingiva, 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 2 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Sanjay Tewari, MDS (9416259534, principalpgids@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of gingival thickness (GT) (time frame: 9 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 7 Feb 2024.