Gingival HyperplasiaEarly Phase 1NCT07169357
Testing the Efficacy of Photobiomodulation Therapy and Hyaluronic Acid Gel on Post-surgical Healing After Gingivectomy
A Early Phase 1 study testing Gengigel and LASER in people with Gingival Hyperplasia and Gingival Hypertrophy, run by Beirut Arab University at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Gingival Hyperplasia, Gingival Hypertrophy, Gingival Overgrowth
- What is being tested?
- Gengigel and LASER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteLebanon
- Study dates
- 11 Nov 2025to Nov 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Mentally disturbed patients
- Excessive gag reflex
- Patients who refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Hyaluronic Acid Gel and Photobiomodulation Therapy on Wound Healing After Surgical Gingivectomy: A Randomized Controlled Clinical Trial
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.
Read the 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
- Being tested
- Gengigel, LASER
- Keywords
- LLLT, PBMT, GO, GE
- Medical subject headings
- Gingival Hyperplasia, Gingival Hypertrophy, Gingival Overgrowth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GengigelDrug
Also called 0.2% hyaluronic acid gel
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.
LASERDevice
Also called Low-level-laser therapy, low-intensity lasers, non-thermal lasers, cold lasers
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
| Study group | Role | What they receive |
|---|---|---|
| test group (Group A) | Active comparator | Surgical sites after gingivectomy procedures will be irradiated with diode laser (Photobiomodulation therapy) then covered with HA Gel. Receives: Drug: Gengigel; Device: LASER |
| test group (Group B) | Active comparator | Surgical sites will be irradiated with diode laser only Receives: Device: LASER |
| control group (group c) | No intervention | No post-surgical therapy will be performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
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
Measured: pre-operative post-operative - on the 7th day - on the 14th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start11 Nov 2025
- Primary completion11 Feb 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beirut Arab University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Rabih Danaf Naim, Beirut Arab University
- Investigators
- Rania Abdel Fahmy, Phd, Study director, Beirut Arab UniversityNayer Abo Saad, Phd, Study chair, Beirut Arab University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169357
- Sponsor's protocol ID
- 2025-H-0160-D-M-0692
- Status last verified
- Nov 2025
- First submitted
- 5 Sep 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37891549
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hyaluronic Acid Gel and Photobiomodulation Therapy on Wound Healing After Surgical Gingivectomy: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07169357
- Acronym / sponsor ID
- 2025-H-0160-D-M-0692
- Conditions
- Gingival Hyperplasia, Gingival Hypertrophy, Gingival Overgrowth, Gingival Enlargement, Photobiomodulation Therapy, Low-level-laser Theraphy
- Keywords
- LLLT, PBMT, GO, GE
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Beirut Arab UniversityUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 11 Feb 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| test group (Group A) | Active comparator | Drug: Gengigel, Device: LASERSurgical sites after gingivectomy procedures will be irradiated with diode laser (Photobiomodulation therapy) then covered with HA Gel. |
| test group (Group B) | Active comparator | Device: LASERSurgical sites will be irradiated with diode laser only |
| control group (group c) | No intervention | –No post-surgical therapy will be performed |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient health ASA I, II
- Average age from 18 to 40 years
- Both genders
- Chronic inflammatory gingival enlargement
- Adequate amount of keratinized tissue.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GengigelAlso: 0.2% hyaluronic acid gelThe 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. | Drug | test group (Group A) |
| LASERAlso: Low-level-laser therapy, low-intensity lasers, non-thermal lasers, cold lasersPBMT 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 | Device | test group (Group A), test group (Group B) |
Primary outcome
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.
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
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
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)
1 secondary outcome
Oral health impact profile 14 questions
Time frame: pre-operative post-operative - on the 7th day - on the 14th day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Results publication: PubMed 37891549Yakout 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rania Abdel Fahmy, Phd study director
Beirut Arab University
Nayer Abo Saad, Phd study chair
Beirut Arab University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gengigel and LASER in people with Gingival Hyperplasia and Gingival Hypertrophy, run by Beirut Arab University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07169357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.