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

NCT07169357 | Enrolling By Invitation Early Phase 1 DMC

• 1 other identifier: 2025-H-0160-D-M-0692
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

LLLT; PBMT; GO; GE

Outcome Measures

Primary Outcomes (2)

• Landry's healing index

  to asses the wound healing progress post-surgically in the 3 groups and see how photobiomodulation therapy and the application of hyaluronic acid can enhance the post-operative period. Five variables are assessed: tissue color, bleeding on palpation, the presence of granulation tissue, the incision margin and suppuration. It ranges from 1 to 5, with 1 indicating poor healing and 5 indicating excellent healing

  Wound healing assessed by implementing Landry, Turnbull and Howley Healing index on the 3rd, 7th, 14th, 21st day, 1 month, 2 months and 3 months after the post-surgical procedure.

• Visual analogue scale

  to asses the subjected level of pain by the patient throughout the healing process with a minimum score of 0 meaning no pain (best) and a maximum score of 10 meaning severe pain (worse)

  Pain perception will be evaluated by using the visual analog scale on the 3rd, 7th, 14th, 21st day and 1 month of periodic follow-up

Secondary Outcomes (1)

• Oral health impact profile 14 questions

  pre-operative post-operative - on the 7th day - on the 14th day

Study Arms (3)

test group (Group A)

ACTIVE COMPARATOR

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

Drug: Gengigel; Device: LASER

test group (Group B)

ACTIVE COMPARATOR

Surgical sites will be irradiated with diode laser only

Device: LASER

control group (group c)

NO INTERVENTION

No post-surgical therapy will be performed

Interventions

Gengigel DRUG

The use of Gingigel or 0.2% hyaluronic gel is expected to enhance healing and decrease discomfort in the post-operative period. It exhibits viscoelastic characteristic which serves as osteo-conductive, anti-edematous, antifungal and bacteriostatic effects.

Also known as: 0.2% hyaluronic acid gel

test group (Group A)

LASER DEVICE

PBMT has markedly been effective in reducing pain, inflammation, edema and postoperative discomfort. It is said to be a natural and effective alternative approach to minimize medicaments prescription such as analgesics, anti-inflammatory or antibiotic drugs. With that said, negative outcomes such as drug side effects, bacterial resistance and post-operative complications can be prevented, thus increasing the success of medical care and assuring a better quality of life

Also known as: Low-level-laser therapy, low-intensity lasers, non-thermal lasers, cold lasers

test group (Group A); test group (Group B)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beirut Arab University: lead

Study Sites (1)

Beirut Arab University

Beirut, Lebanon

Location

Related Publications (1)

• Yakout BK, Kamel FR, Khadr MAEA, Heikal LAH, El-Kimary GI. Efficacy of hyaluronic acid gel and photobiomodulation therapy on wound healing after surgical gingivectomy: a randomized controlled clinical trial. BMC Oral Health. 2023 Oct 27;23(1):805. doi: 10.1186/s12903-023-03519-5.

  PMID: 37891549 RESULT

MeSH Terms

Conditions

Gingival Hyperplasia; Gingival Hypertrophy; Gingival Overgrowth

Interventions

Lasers; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Rania Abdel Fahmy, Phd

  Beirut Arab University

  STUDY DIRECTOR

• Nayer Abo Saad, Phd

  Beirut Arab University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 11, 2025
• Study Start: November 11, 2025
• Primary Completion: February 11, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)