Laser Bandage and Surgical Stent as Palatal Donor Site Dressing After Free Gingival Graft Surgery.

Palate; Wound Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05841641
• Other study ID #: 02_D012_117073
• Status: Completed
• Phase: N/A
• Start date: June 12, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2023
• Source: Krishnadevaraya College of Dental Sciences & Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Patients willing to participate in the study.

2. Patients between the age group of 25 to 55 years.

3. Systemically healthy subjects, non-smokers, no record of allergies

4. Patients with esthetic concerns.

5. Patients with palatal mucosa thickness greater than 4mm

6. Absence of periapical or palatal pathologies and the absence of excessive forces (e.g. mechanical forces from orthodontics and traumatic occlusion).

7. Full mouth plaque score (FMPS) < 20%, Full mouth bleeding score (FMBS) < 20%.

Exclusion Criteria:

1. Patients with any systemic diseases.

2. Patients with a history of coagulation disorders.

3. Patients with immunological disorders.

4. Pregnant and lactating females.

5. History of tobacco usage in any form.

6. Patients taking medication that interfere with healing.

7. Patients with palatal mucosa thickness lesser than 2.5mm.

8. Patients who have undergone periodontal surgery within 6 months from the time they enrolled in the study.

Related Conditions & MeSH terms

• Palate; Wound

Intervention

Device:
• Laser Bandage
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.

Procedure:
• Hemostatic agent with surgical stent
Following graft harvesting, the donor site was secured with a hemostatic agent and protected with a palatal stent

Locations

Country	Name	City	State
India	Krishnadevaraya college of dental sciences	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EPITHELIALIZATION	Hydrogen peroxide bubble test	30 days