Testing the Efficacy of Photobiomodulation Therapy and Hyaluronic Acid Gel on Post-surgical Healing After Gingivectomy

Beirut Arab University

Status and phase: Invitation-only; Early Phase 1

Conditions: Gingival Hypertrophy; Gingival Hyperplasia; Low-level-laser Theraphy; Photobiomodulation Therapy; Gingival Enlargement; Gingival Overgrowth

Treatments: Drug: Gengigel; Device: LASER

Study type: Interventional

Funder types: Other

Identifiers

NCT07169357

2025-H-0160-D-M-0692

Details and patient eligibility

About

This study consists of random patient selection and allocating them in 3 different groups. After being fit to be included according to the protocol's criteria and signing an informed consent, patients will be distributed after performing a dental surgery known as gingivectomy. Gingivectomy has been classified as the gold standard treatment option for the control of gingival enlargement. Wound recovery after gingivectomy and gingivoplasty occurs by secondary intention healing, thus post-surgical wounds can be strongly associated with discomfort, pain and delayed healing. For that reason, the first group will consist of 13 patients who will be exposed to hyaluronic acid gel or gingigel and photobiomodulation therapy to see if there is significant results in the post-operative healing phase. The second group will also consist of 13 patients who will undergo only photobiomodulation therapy. While the third group will have no clinical supportive care besides follow-up and analgesics upon request.

All the values will be determined by using scores such as Visual analogue scale for pain, Landry's index for healing assessment and oral health quality of life, which consists of 14 questions to asses the enhancement of everyday problems affected by dental situations.

Each case will be followed-up for 3 months post-operative.

Full description

The study group consisted of thirty-nine surgical gingivectomy wound sites on patients presenting with gingival hypertrophy on maxillary or mandibular anterior region. Groups will be randomly and equally divided into three groups, Group-A (Test Group 1): Surgical sites after gingivectomy procedures will be irradiated with diode laser (Photobiomodulation therapy) at (940 nm, 0.21 W) with a fiber tip diameter of 400μm for 30 seconds, then covered with HA Gel. Group-B (Test Group 2): Surgical sites will be irradiated with diode laser only at (940 nm, 0.21 W). Group-C (Control Group): No post-surgical therapy will be performed. Wound healing was assessed by implementing Landry, Turnbull and Howley Healing index, while pain perception was objectively evaluated by the patients using the visual analog scale (VAS). To further evaluate the patient's quality of life, Oral Health Impact Profile (OHIP-14) records will be obtained before and after gingivectomy.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient health ASA I, II
• Average age from 18 to 40 years
• Both genders
• Chronic inflammatory gingival enlargement
• Adequate amount of keratinized tissue.
• Well educated patients as post-operative instructions need to be followed precisely.

Exclusion criteria

• Smokers
• Bad oral hygiene
• Allergy to Hyaluronic acid or cosmetic fillers containing H.A
• Any patient under oral contraceptives or immunosuppressive drugs
• Patients undergoing radiotherapy or chemotherapy
• Pregnant or lactating mothers
• Mentally disturbed patients
• Excessive gag reflex
• Patients who refuse to sign informed consent.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

test group (Group A)

Active Comparator group

Description:

Surgical sites after gingivectomy procedures will be irradiated with diode laser (Photobiomodulation therapy) then covered with HA Gel.

Treatment:

Device: LASER

Drug: Gengigel

test group (Group B)

Active Comparator group

Description:

Surgical sites will be irradiated with diode laser only

Treatment:

Device: LASER

control group (group c)

No Intervention group

Description:

No post-surgical therapy will be performed