An Early Phase 1 interventional study of Gengigel and LASER in Gingival Hyperplasia, Gingival Hypertrophy and Gingival Overgrowth, sponsored by Beirut Arab University. Enrolling by invitation at 1 site in Lebanon. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-11-14.
Sponsored by Beirut Arab University · Early Phase 1, Interventional, and Supportive care
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.
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.
18 studies on the registry are indexed under Gingival Overgrowth; 1 is open to participants now.
This study's planned enrollment of 38 is above the median of 30 across 17 interventional studies indexed under Gingival Overgrowth.
Browse Gingival Overgrowth studies →Beirut Arab University is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgical sites after gingivectomy procedures will be irradiated with diode laser (Photobiomodulation therapy) then covered with HA Gel.
Drug: Gengigel · Device: LASER
Surgical sites will be irradiated with diode laser only
Device: LASER
No post-surgical therapy will be performed
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
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
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
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
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)
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
Oral health impact profile 14 questions
to asses the quality of life of patients prior the surgery due to their condition to asses the enhancement of the patient's condition after the surgery and asses how the post-operative interventions bettered their post-operative experience. To asses the condition you sum the numerical values of each of the 14 items with a 5-point likert scale 0= never 1= hardly ever 2= ocassionally 3=fairly often 4= very often then you sum the scores of all 14 question to get a total score from 0-56. closer to 56 = greater negative impact of oral health problems on the quality of life closer to 0 =better oral-health related quality of life
Time frame: pre-operative post-operative - on the 7th day - on the 14th day
Plan to share: No
Started Nov 2025 (actual). Primary completion is estimated for Feb 2026, 3 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Hyaluronic Acid
Beirut Arab University