Testing the Efficacy of Photobiomodulation Therapy and Hyaluronic Acid Gel on Post-surgical Healing After Gingivectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gengigel, LASER.
- Who it may be relevant to
- Registry conditions: Gingival Hyperplasia, Gingival Hypertrophy, Gingival Overgrowth, Gingival Enlargement. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Lebanon
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Hyaluronic Acid Gel and Photobiomodulation Therapy on Wound Healing After Surgical Gingivectomy: A Randomized Controlled Clinical Trial
Overview
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.
Interventions
- Drug 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. - Device 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
Primary outcome measures
- Landry's healing index [Time frame: 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 [Time frame: 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 outcome measures (1)
- Oral health impact profile 14 questions [Time frame: pre-operative post-operative - on the 7th day - on the 14th day]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Lebanon · 1 center
- Beirut Arab University — Beirut
Publications
- 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
Identifiers
NCT: NCT07169357 · 2025-H-0160-D-M-0692