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

NCT ID: NCT07169357

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-11
• Study Completion Date: 2026-11-30

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

test group (Group A)

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

Group Type: ACTIVE_COMPARATOR

Gengigel

Intervention Type: 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.

LASER

Intervention Type: 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

test group (Group B)

Surgical sites will be irradiated with diode laser only

Group Type: ACTIVE_COMPARATOR

LASER

Intervention Type: 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

control group (group c)

No post-surgical therapy will be performed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gengigel

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.

Intervention Type: DRUG

LASER

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

Intervention Type: DEVICE

Other Intervention Names

0.2% hyaluronic acid gel; Low-level-laser therapy; low-intensity lasers; non-thermal lasers; cold lasers

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beirut Arab University

OTHER

Sponsor Role: lead

Responsible Party

Hanan Rabih Danaf Naim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rania Abdel Fahmy, Phd

Role: STUDY_DIRECTOR

Beirut Arab University

Nayer Abo Saad, Phd

Role: STUDY_CHAIR

Beirut Arab University

Locations

Beirut Arab University

Beirut, , Lebanon

Countries

Lebanon

References

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.

Reference Type: RESULT

PMID: 37891549 (View on PubMed)

Other Identifiers

2025-H-0160-D-M-0692

Identifier Type: -

Identifier Source: org_study_id