Palate; WoundNCT05841641
Laser Bandage and Surgical Stent as Palatal Donor Site Dressing After Free Gingival Graft Surgery.
A study testing Laser Bandage and Hemostatic agent with surgical stent in people with Palate; Wound, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
The free gingival graft (FGG) procedure is a harvesting technique that creates an open wound that heals by secondary intention. Retarded wound healing, excessive bleeding, and postoperative pain have been reported after FGG procedures. Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Palate; Wound
- What is being tested?
- Laser Bandage and Hemostatic agent with surgical stent
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 12 Jun 2021to 1 Dec 2022
- 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 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients willing to participate in the study.
- Patients between the age group of 25 to 55 years.
- Systemically healthy subjects, non-smokers, no record of allergies
- Patients with esthetic concerns.
- Patients with palatal mucosa thickness greater than 4mm
- Absence of periapical or palatal pathologies and the absence of excessive forces (e.g. mechanical forces from orthodontics and traumatic occlusion).
- Full mouth plaque score (FMPS) < 20%, Full mouth bleeding score (FMBS) < 20%.
Who cannot join
- Patients with any systemic diseases.
- Patients with a history of coagulation disorders.
- Patients with immunological disorders.
- Pregnant and lactating females.
- History of tobacco usage in any form.
- Patients taking medication that interfere with healing.
- Patients with palatal mucosa thickness lesser than 2.5mm.
- Patients who have undergone periodontal surgery within 6 months from the time they enrolled in the study.
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157
About this study
Official title: A Comparative Evaluation of Laser Bandage and Surgical Stent as Palatal Donor Site Dressing After Free Gingival Graft Surgery. A Randomized Control Clinical Trial
The free gingival graft (FGG) procedure is a harvesting technique that creates an open wound that heals by secondary intention. Retarded wound healing, excessive bleeding, and postoperative pain have been reported after FGG procedures. Hemostatic agents include ferric sub-sulfate solution, absorbable synthetic collagen, absorbable gelatin sponge, or oxidized regenerated cellulose. The agents are often combined with a surgical stent designed to cover the donor site, providing protection and pressure hemostasis. Diode laser also exhibits excellent thermal effects with deep tissue penetrative properties, to enhance coagulation. Laser Bandage (LB) could also enhance wound healing and reduce subjective postoperative complications in the palatal donor area after harvesting FGG similarly.
Read the detailed description
NEED FOR THE STUDY Autogenous soft tissue grafts are widely used to increase the width of keratinized tissue.1 The free gingival graft (FGG) procedure is a harvesting technique that creates an open wound that heals by secondary intention. Retarded wound healing, excessive bleeding, and postoperative pain have been reported after FGG procedures. To overcome these problems, several techniques and products have been developed. Hemostatic agents such as ferric sub-sulfate solution, absorbable synthetic collagen, absorbable gelatin sponge, or oxidized regenerated cellulose. The agents are often combined with a surgical stent designed to cover the donor site, providing protection and pressure hemostasis. However, these materials may cause adverse effects such as allergies or foreign body reactions or retarded healing of the wound. An optimal method to reduce patient morbidity and enhance early wound healing in the palatal donor site has not yet been defined. Therefore, obtaining new materials that provide better wound care by decreasing bacterial contamination and enhancing wound healing has been considered an essential demand.
Recently, Lasers are also considered a good choice for wound coverage of the donor site due to effective tissue ablation, and hemostatic and bactericidal effects. Laser exhibits hemostatic effects due to its 'hot-tip' effect caused by heat accumulation at the end of the fibre. This produces a thick coagulation layer called a laser bandage or biological bandage. It is also referred to as the 'char layer' or 'eschar on the treated surface. Coleton placed a biological bandage in the donor site using C02 Laser, set at 5W continuous wave in ablative mode. Low and Convissar used erbium laser settings of low wattage with no water, some air and few pulses per second to create laser bandage to achieve coagulation. Since Diode laser also exhibits excellent thermal effects with deep tissue penetrative properties, it enhances coagulation. the investigator proposes Laser Bandage (LB) could also enhance wound healing and reduces subjective postoperative complications in the palatal donor area after harvesting FGG in a similar way.
To date, no studies have evaluated and compared if the diode laser bandage method is more effective than other palatal wound protection methods. Hence, the current study which is first of a kind is undertaken with the objectives of evaluating the effectiveness of Diode LB in achieving donor site hemostasis and comparing wound healing with a standardized palatal haemostatic agent in gel form with the surgical stent in a randomized controlled fashion.
- Conditions
- Palate; Wound
- Being tested
- Laser Bandage, Hemostatic agent with surgical stent
- Keywords
- LASER BANDAGE, WOUND HEALING
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser BandageDevice
Also called Diode laser (A.R.C- Fox)
The Diode Laser will create a biological bandage at a wavelength of 810 nm, set at 5W in continuous-wave mode, applied via a 400-µm optical fibre.
Hemostatic agent with surgical stentProcedure or surgery
Also called Abgel with surgical stent
Following graft harvesting, the donor site was secured with a hemostatic agent and protected with a palatal stent
| Study group | Role | What they receive |
|---|---|---|
| Laser Bandage | Experimental | Graft site charred with Diode Laser at 5 Watts to created charred layer Receives: Device: Laser Bandage |
| Hemostatic agent with surgical stent | Experimental | Graft donor site secured with hemostatic agent with surgical stent Receives: Procedure: Hemostatic agent with surgical stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
EPITHELIALIZATION
Hydrogen peroxide bubble test
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start12 Jun 2021
- Primary completion1 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palate; WoundStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prabhuji MLV, Principal investigator, Rajiv Gandhi University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841641
- Sponsor's protocol ID
- 02_D012_117073
- Status last verified
- Apr 2023
- First submitted
- 6 Feb 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coleton S. Lasers in surgical periodontics and oral medicine. Dent Clin North Am. 2004 Oct;48(4):937-62, vii. doi: 10.1016/j.cden.2004.05.008.
PubMed 15464559
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Laser Bandage and Surgical Stent as Palatal Donor Site Dressing After Free Gingival Graft Surgery. A Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT05841641
- Acronym / sponsor ID
- 02_D012_117073
- Conditions
- Palate; Wound
- Keywords
- LASER BANDAGE, WOUND HEALING
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 12 Jun 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 3 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 free gingival graft (FGG) procedure is a harvesting technique that creates an open wound that heals by secondary intention. Retarded wound healing, excessive bleeding, and postoperative pain have been reported after FGG procedures. Hemostatic agents include ferric sub-sulfate solution, absorbable synthetic collagen, absorbable gelatin sponge, or oxidized regenerated cellulose. The agents are often combined with a surgical stent designed to cover the donor site, providing protection and pressure hemostasis. Diode laser also exhibits excellent thermal effects with deep tissue penetrative properties, to enhance coagulation. Laser Bandage (LB) could also enhance wound healing and reduce subjective postoperative complications in the palatal donor area after harvesting FGG similarly.
Detailed description
NEED FOR THE STUDY Autogenous soft tissue grafts are widely used to increase the width of keratinized tissue.1 The free gingival graft (FGG) procedure is a harvesting technique that creates an open wound that heals by secondary intention. Retarded wound healing, excessive bleeding, and postoperative pain have been reported after FGG procedures. To overcome these problems, several techniques and products have been developed. Hemostatic agents such as ferric sub-sulfate solution, absorbable synthetic collagen, absorbable gelatin sponge, or oxidized regenerated cellulose. The agents are often combined with a surgical stent designed to cover the donor site, providing protection and pressure hemostasis. However, these materials may cause adverse effects such as allergies or foreign body reactions or retarded healing of the wound. An optimal method to reduce patient morbidity and enhance early wound healing in the palatal donor site has not yet been defined. Therefore, obtaining new materials that provide better wound care by decreasing bacterial contamination and enhancing wound healing has been considered an essential demand.
Recently, Lasers are also considered a good choice for wound coverage of the donor site due to effective tissue ablation, and hemostatic and bactericidal effects. Laser exhibits hemostatic effects due to its 'hot-tip' effect caused by heat accumulation at the end of the fibre. This produces a thick coagulation layer called a laser bandage or biological bandage. It is also referred to as the 'char layer' or 'eschar on the treated surface. Coleton placed a biological bandage in the donor site using C02 Laser, set at 5W continuous wave in ablative mode. Low and Convissar used erbium laser settings of low wattage with no water, some air and few pulses per second to create laser bandage to achieve coagulation. Since Diode laser also exhibits excellent thermal effects with deep tissue penetrative properties, it enhances coagulation. the investigator proposes Laser Bandage (LB) could also enhance wound healing and reduces subjective postoperative complications in the palatal donor area after harvesting FGG in a similar way.
To date, no studies have evaluated and compared if the diode laser bandage method is more effective than other palatal wound protection methods. Hence, the current study which is first of a kind is undertaken with the objectives of evaluating the effectiveness of Diode LB in achieving donor site hemostasis and comparing wound healing with a standardized palatal haemostatic agent in gel form with the surgical stent in a randomized controlled fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Bandage | Experimental | Device: Laser BandageGraft site charred with Diode Laser at 5 Watts to created charred layer |
| Hemostatic agent with surgical stent | Experimental | Procedure: Hemostatic agent with surgical stentGraft donor site secured with hemostatic agent with surgical stent |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients willing to participate in the study.
- Patients between the age group of 25 to 55 years.
- Systemically healthy subjects, non-smokers, no record of allergies
- Patients with esthetic concerns.
- Patients with palatal mucosa thickness greater than 4mm
Key exclusion criteria (8 listed)
- Patients with any systemic diseases.
- Patients with a history of coagulation disorders.
- Patients with immunological disorders.
- Pregnant and lactating females.
- History of tobacco usage in any form.
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 |
|---|---|---|
| Laser BandageAlso: Diode laser (A.R.C- Fox)The Diode Laser will create a biological bandage at a wavelength of 810 nm, set at 5W in continuous-wave mode, applied via a 400-µm optical fibre. | Device | Laser Bandage |
| Hemostatic agent with surgical stentAlso: Abgel with surgical stentFollowing graft harvesting, the donor site was secured with a hemostatic agent and protected with a palatal stent | Procedure or surgery | Hemostatic agent with surgical stent |
Primary outcome
EPITHELIALIZATION
Time frame: 30 days
Hydrogen peroxide bubble test
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 3 May 2023.
- Results publication: PubMed 15464559Coleton S. Lasers in surgical periodontics and oral medicine. Dent Clin North Am. 2004 Oct;48(4):937-62, vii. doi: 10.1016/j.cden.2004.05.008.
- Individual participant dataSharing planned: No
Related trials for Palate; Wound
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Recruiting
Dynamics of Wound Healing in Patients With Obesity
Wound Healing
Active, not recruiting
Effect of Frankincense Versus Palatal Stent on Palatal Donor Site Healing
Palatal Donor Site Wound Healing
Recruiting
Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques
Mucosal Erosion, Gingival Recession
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.
Prabhuji MLV principal investigator
Rajiv Gandhi University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Bandage and Hemostatic agent with surgical stent in people with Palate; Wound, run by Krishnadevaraya College of Dental Sciences & Hospital 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 7 inclusion and 8 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 3 May 2023. 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?
EPITHELIALIZATION (time frame: 30 days). 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 NCT05841641, which also lists 1 linked publication.
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 3 May 2023.