Gingival OvergrowthCLSHGTAGSNCT03569683
Comparison Between Laser, Synthetic Gel and Herbal Gel as Topical Agents After Gum Surgery
A study testing External bevel gingivectomy, Diode laser Biostimulation and Hyaluronic acid (Gengigel) topical application. in people with Gingival Overgrowth, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
Trial summary
This study would be conducted to assess the effectiveness of low-level laser therapy, hyaluronic acid gel and herbal gel as adjunctive aids in the healing of gingivectomy wounds. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Overgrowth
- What is being tested?
- External bevel gingivectomy, Diode laser Biostimulation and Hyaluronic acid (Gengigel) topical application.
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 30 May 2018to 30 Oct 2018
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria: Gingival enlargement index greater than or equal to 2mm
Exclusion Criteria: Infrabony Pockets Diabetic patients Smokers.
-
Trial locations and contacts
1 site in 1 country.
India1 site
Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre
Hyderabad, Telangana, 500060
About this study
Official title: Efficacy of Low-level Laser Therapy, Hyaluronic Acid Gel and Herbal Gel as Adjunctive Tools in Gingivectomy Wound Healing-A Randomised Comparative Clinical and Histological Study
This study would be conducted to assess the effectiveness of low-level laser therapy, hyaluronic acid gel and herbal gel as adjunctive aids in the healing of gingivectomy wounds. As the gingivectomy wound heals by secondary intention, this study aims to compare the healing potential of low-level laser therapy, hyaluronic acid gel and herbal gel when applied topically at baseline, 1st day,3rd day and 7th day after gingivectomy procedure.
Read the detailed description
Low-level laser therapy applied to soft tissues stimulates specific metabolic processes in healing wounds. Major changes observed in wounds treated with low-level laser therapy(LLLT) include increased healthy granulation tissue formation with early epithelization, increased fibroblast proliferation and matrix synthesis.
Hyaluronic acid is a polysaccharide gel and it has many properties that make it a potentially ideal molecule for assisting in wound healing by inducing early granulation tissue formation, inhibiting inflammation, providing epithelial turnover and also aiding in connective tissue angiogenesis.
Hiora gel is a herbal astringent gel which helps in wound healing, reduces inflammation and also alleviates pain.
- Conditions
- Gingival Overgrowth
- Being tested
- External bevel gingivectomy, Diode laser Biostimulation, Hyaluronic acid (Gengigel) topical application., Herbal gel (Hiora SG) topical application
- Medical subject headings
- Gingival Overgrowth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External bevel gingivectomyProcedure or surgery
Also called Conventional Gingivectomy
External bevel gingivectomy will be performed on 30 patients wherein the suprabony pockets will be eliminated with the help of a Bard parker blade no 15. The incision would be given 1mm apical to the pockets which would be marked by a Crane and Kaplan pocket marker, then the incision would be given and the tissue would be removed with the help of kirkland and orbans knives and the gingiva would be shaped. After the surgical procedure the patients would be treated either with the Diode laser(Group A), Hyaluronic acid gel (Group B), or Herbal gel(Group C).
Diode laser BiostimulationDevice
After gingivectomy, laser irradiation will be done using bio-stimulation tip in the anterior sextants of the mouth. (Group A)
Hyaluronic acid (Gengigel) topical application.Other
After gingivectomy, Hyaluronic acid gel(Gengigel) will be applied topically. Then it will be covered with a tin foil and periodontal dressing would be given. (Group B)
Herbal gel (Hiora SG) topical applicationOther
After gingivectomy, Herbal gel(Hiora SG) will be applied topically. Then it will be covered with a tin foil and periodontal dressing would be given. (Group C)
| Study group | Role | What they receive |
|---|---|---|
| Interventional Single arm | Experimental | Group A- Diode laser biostimulation on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery.
Group B- Hyaluronic acid (Gengigel) topical application on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery.
Group C- Herbal gel (Hiora SG) topical application on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery. Receives: Procedure: External bevel gingivectomy; Device: Diode laser Biostimulation; Other: Hyaluronic acid (Gengigel) topical application.; Other: Herbal gel (Hiora SG) topical application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Assessment
Change in gingival tissue healing will be assessed.0.5 mm of tissue will be taken from the interdental papilla distal to the canine and will be processed for examination using hematoxiline and eosin and picrosirus staining.
Measured: Immediately Postoperatively and 6 weeks after gingivectomy.
Secondary outcomes (1)
Clinical Parameters
Gingival tissue healing will be assessed on a 10 point visual analogue scale.Score in each tooth will be taken including one full interdental papilla
Visual Analogue Scale: will be used to quantify pain levels and patient's discomfort. The VAS consists of a horizontal line of 10 cm (100 mm) with two end-points representing 'no pain' and 'worst pain imaginable'. Patients will be asked to rate their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the 'no pain' marker is then measured with a ruler giving a pain score out of 10.
0: No pain 1-3: Slight pain 3.1-6: Moderate pain 6.1-10: Severe pain.
Measured: 6 weeks after Gingivectomy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start30 May 2018
- Primary completion15 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival OvergrowthStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The patients will be equally divided into three groups. (Groups A,B\&C) All the cases will be prepared preoperatively with scaling and root planing, oral hygeine instructions, occlusal equilibration and dietary evaluation. External bevel gingivectomy will be performed wherein the inflamed gingiva will be excised and shaped. Group A- The Surgical site will be treated with diode laser following gingivectomy procedure, immediately and on the 1st,3rd and 7th day after surgery. Group B- Hyaluronic acid will be applied topically to the surgical site immediately after gingivectomy, tin foil would be placed and periodontal dressing given, and on the 1st,3rd and 7th day postoperatively. Group C- Herbal gel will be applied topically and tin foil placed over which a periodontal dressing would be given immediately after the surgery and on the 1st,3rd and 7th day postoperatively.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sana priyanka, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- Sana Priyanka Reddy, (MDS), Principal investigator, PG Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569683
- Sponsor's protocol ID
- PMVIDS
- Other IDs
- 16201105032D
- Acronym
- CLSHGTAGS
- Status last verified
- Nov 2018
- First submitted
- 29 May 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amorim JC, de Sousa GR, de Barros Silveira L, Prates RA, Pinotti M, Ribeiro MS. Clinical study of the gingiva healing after gingivectomy and low-level laser therapy. Photomed Laser Surg. 2006 Oct;24(5):588-94. doi: 10.1089/pho.2006.24.588.
PubMed 17069488Martu S, Amalinei C, Tatarciuc M, Rotaru M, Potarnichie O, Liliac L, Caruntu ID. Healing process and laser therapy in the superficial periodontium: a histological study. Rom J Morphol Embryol. 2012;53(1):111-6.
PubMed 22395509
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low-level Laser Therapy, Hyaluronic Acid Gel and Herbal Gel as Adjunctive Tools in Gingivectomy Wound Healing-A Randomised Comparative Clinical and Histological Study
- ClinicalTrials.gov ID
- NCT03569683
- Acronym / sponsor ID
- CLSHGTAGS / PMVIDS
- Conditions
- Gingival Overgrowth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 26 Jun 2018 (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.
This study would be conducted to assess the effectiveness of low-level laser therapy, hyaluronic acid gel and herbal gel as adjunctive aids in the healing of gingivectomy wounds. As the gingivectomy wound heals by secondary intention, this study aims to compare the healing potential of low-level laser therapy, hyaluronic acid gel and herbal gel when applied topically at baseline, 1st day,3rd day and 7th day after gingivectomy procedure.
Detailed description
Low-level laser therapy applied to soft tissues stimulates specific metabolic processes in healing wounds. Major changes observed in wounds treated with low-level laser therapy(LLLT) include increased healthy granulation tissue formation with early epithelization, increased fibroblast proliferation and matrix synthesis.
Hyaluronic acid is a polysaccharide gel and it has many properties that make it a potentially ideal molecule for assisting in wound healing by inducing early granulation tissue formation, inhibiting inflammation, providing epithelial turnover and also aiding in connective tissue angiogenesis.
Hiora gel is a herbal astringent gel which helps in wound healing, reduces inflammation and also alleviates pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patients will be equally divided into three groups. (Groups A,B\&C) All the cases will be prepared preoperatively with scaling and root planing, oral hygeine instructions, occlusal equilibration and dietary evaluation. External bevel gingivectomy will be performed wherein the inflamed gingiva will be excised and shaped. Group A- The Surgical site will be treated with diode laser following gingivectomy procedure, immediately and on the 1st,3rd and 7th day after surgery. Group B- Hyaluronic acid will be applied topically to the surgical site immediately after gingivectomy, tin foil would be placed and periodontal dressing given, and on the 1st,3rd and 7th day postoperatively. Group C- Herbal gel will be applied topically and tin foil placed over which a periodontal dressing would be given immediately after the surgery and on the 1st,3rd and 7th day postoperatively.
| Arm | Type | Receives |
|---|---|---|
| Interventional Single arm | Experimental | Procedure: External bevel gingivectomy, Device: Diode laser Biostimulation, Other: Hyaluronic acid (Gengigel) topical application., Other: Herbal gel (Hiora SG) topical applicationGroup A- Diode laser biostimulation on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery. Group B- Hyaluronic acid (Gengigel) topical application on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery. Group C- Herbal gel (Hiora SG) topical application on surgical site immediately after external bevel gingivectomy and on 1st,3rd, and 7th day after surgery. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| External bevel gingivectomyAlso: Conventional GingivectomyExternal bevel gingivectomy will be performed on 30 patients wherein the suprabony pockets will be eliminated with the help of a Bard parker blade no 15. The incision would be given 1mm apical to the pockets which would be marked by a Crane and Kaplan pocket marker, then the incision would be given and the tissue would be removed with the help of kirkland and orbans knives and the gingiva would be shaped. After the surgical procedure the patients would be treated either with the Diode laser(Group A), Hyaluronic acid gel (Group B), or Herbal gel(Group C). | Procedure or surgery | Interventional Single arm |
| Diode laser BiostimulationAfter gingivectomy, laser irradiation will be done using bio-stimulation tip in the anterior sextants of the mouth. (Group A) | Device | Interventional Single arm |
| Hyaluronic acid (Gengigel) topical application.After gingivectomy, Hyaluronic acid gel(Gengigel) will be applied topically. Then it will be covered with a tin foil and periodontal dressing would be given. (Group B) | Other | Interventional Single arm |
| Herbal gel (Hiora SG) topical applicationAfter gingivectomy, Herbal gel(Hiora SG) will be applied topically. Then it will be covered with a tin foil and periodontal dressing would be given. (Group C) | Other | Interventional Single arm |
Primary outcome
Histological Assessment
Time frame: Immediately Postoperatively and 6 weeks after gingivectomy.
Change in gingival tissue healing will be assessed.0.5 mm of tissue will be taken from the interdental papilla distal to the canine and will be processed for examination using hematoxiline and eosin and picrosirus staining.
1 secondary outcome
Clinical Parameters
Time frame: 6 weeks after Gingivectomy procedure
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 6 Nov 2018.
- Background: PubMed 17069488Amorim JC, de Sousa GR, de Barros Silveira L, Prates RA, Pinotti M, Ribeiro MS. Clinical study of the gingiva healing after gingivectomy and low-level laser therapy. Photomed Laser Surg. 2006 Oct;24(5):588-94. doi: 10.1089/pho.2006.24.588.
- Background: PubMed 22395509Martu S, Amalinei C, Tatarciuc M, Rotaru M, Potarnichie O, Liliac L, Caruntu ID. Healing process and laser therapy in the superficial periodontium: a histological study. Rom J Morphol Embryol. 2012;53(1):111-6.
- Individual participant dataSharing planned: No
Related trials for Gingival Overgrowth
Enrolling by invitationEarly Phase 1
Testing the Efficacy of Photobiomodulation Therapy and Hyaluronic Acid Gel on Post-surgical Healing After Gingivectomy
Gingival Hyperplasia, Gingival Hypertrophy
Recruiting
The Effect of Ozone Therapy on Gingivoplasty
Gingival Enlargement
Recruiting
Periodontal Plastic Reconstruction of Soft Tissue Dehiscences After the Removal of Localized Gingival Enlargements
Localized Gingival Enlargement, Epulides
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.
Sana Priyanka Reddy, (MDS) principal investigator
PG Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External bevel gingivectomy, Diode laser Biostimulation and Hyaluronic acid (Gengigel) topical application. in people with Gingival Overgrowth, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre 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?
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 6 Nov 2018. 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?
Histological Assessment (time frame: Immediately Postoperatively and 6 weeks after gingivectomy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569683, which also lists 2 linked publications.
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 6 Nov 2018.