Gingival EnlargementNCT07034625
Comparative Evaluation of Hyaluronic Acid Spray and Low-Level Laser Therapy on Wound Healing Following Gingivectomy
A study testing Low Level Laser Therapy and Hyaluronic Acid Spray in people with Gingival Enlargement, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Gingival enlargement may impair oral hygiene, esthetics, and periodontal health, and gingivectomy is commonly performed when non-surgical treatment is insufficient. Because gingivectomy wounds heal by secondary intention, postoperative wound healing and pain control are clinically important. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gingival Enlargement
- What is being tested?
- Low Level Laser Therapy and Hyaluronic Acid Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Systemically healthy
- Having chronic inflammatory gingival hyperplasia affecting at least 6 teeth symmetrically in the maxillary or mandibular anterior region with gingivectomy indication
- No usage of any medication affecting periodontal tissues or causing gingival hyperplasia such as antiepileptics, immunosupresors or calcium channel blockers
- No history of periodontitis with attachment and bone loss
Who cannot join
- Having systemic disease
- Pregnancy or breastfeeding
- Smoking
- Inadequate oral hygiene
- Antibiotic usage for the past six months
Trial locations and contacts
1 site in 1 country.
About this study
Gingival enlargement may impair oral hygiene, esthetics, and periodontal health, and gingivectomy is commonly performed when non-surgical treatment is insufficient. Because gingivectomy wounds heal by secondary intention, postoperative wound healing and pain control are clinically important. Low-level laser therapy and hyaluronic acid are adjunctive approaches that may support tissue healing through different biological mechanisms.
This randomized controlled clinical trial compared the effects of topical 0.04% high-molecular-weight hyaluronic acid spray and low-level laser therapy on early wound healing and postoperative pain following gingivectomy. Sixty-four systemically healthy patients requiring gingivectomy were randomly assigned to receive either hyaluronic acid spray applied twice daily for 7 days or 940-nm diode laser therapy applied on postoperative days 0, 3, 5, and 7. Wound healing was assessed using standardized clinical photographs and digital planimetric analysis at baseline and on postoperative days 3, 7, and 14. Postoperative pain was evaluated using a visual analogue scale, and periodontal parameters were recorded at baseline and 6 weeks.
The study aimed to compare these two adjunctive postoperative wound-management approaches after gingivectomy.
- Conditions
- Gingival Enlargement
- Being tested
- Low Level Laser Therapy, Hyaluronic Acid Spray
- Keywords
- low-level laser therapy, gingivectomy, hyaluronic acid
- Medical subject headings
- Gingival Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyOther
A 940-nm diode laser was applied to the gingivectomy wound area on postoperative days 0, 3, 5, and 7. The laser parameters were set as follows: 3 W power output, 1.07 W/cm² power density, 2.8 cm² probe spot size, continuous wave mode, 1-mm application distance, and non-contact stationary application. The laser was applied for 120 seconds per session.
Hyaluronic Acid SprayOther
Participants received a 0.04% high-molecular-weight hyaluronic acid spray after gingivectomy. They were instructed to apply the spray to the surgical wound area twice daily for the first 7 postoperative days.
| Study group | Role | What they receive |
|---|---|---|
| Low Level Laser Therapy | Active comparator | Participants in this group received low-level laser therapy after gingivectomy. A 940-nm diode laser was applied to the surgical wound area on postoperative days 0, 3, 5, and 7. The laser parameters were 3 W power output, 1.07 W/cm² power density, 2.8 cm² probe spot size, continuous wave mode, 1-mm application distance, and non-contact stationary application for 120 seconds per session. Receives: Other: Low Level Laser Therapy |
| Hyaluronic Acid Spray | Active comparator | Participants in this group received topical 0.04% high-molecular-weight hyaluronic acid spray after gingivectomy. Patients were instructed to apply the spray to the surgical wound area twice daily for the first 7 postoperative days. Receives: Other: Hyaluronic Acid Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing Percentage
Wound healing was assessed by measuring the surgical wound surface area using standardized clinical photographs and digital planimetric analysis with ImageJ software. At baseline and on postoperative days 3, 7, and 14, the gingivectomy wound area was stained with an erythrosin-based plaque-disclosing agent to identify non-epithelialized or insufficiently keratinized areas. The healing percentage was calculated by comparing the wound area at each postoperative time point with the baseline wound area using the following formula: Healing (%) = [(Baseline wound area - Wound area at time point) / Baseline wound area] × 100.
Measured: Baseline, postoperative day 3, day 7, and day 14
Secondary outcomes (4)
Postoperative Pain Score (VAS)
Postoperative pain was assessed using a 10-cm Visual Analogue Scale (VAS). Participants were asked to mark their perceived pain intensity on a horizontal line ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain.
Measured: Postoperative day 1, day 3, day 7, and day 14
Gingival Index
The GI was measured at six sites per tooth, according to Löe \& Silness:
0- Normal gingiva;
- Mild inflammation with slight color change, mild alteration of gingival surface structure and no bleeding on probing;
- Moderate inflammation with edema, redness, swelling and bleeding on probing;
- Severe inflammation with marked edema and redness, ulceration and tendency to bleed spontaneously.
Measured: Baseline and 6 weeks postoperatively
Full Mouth Bleeding Score
FMBS: Bleeding on probing was assessed dichotomously as present or absent at six sites per tooth. The Full Mouth Bleeding Score was calculated as the percentage of bleeding-positive sites relative to the total number of examined sites.
Measured: Baseline and 6 weeks postoperatively
Probing Pocket Depth
Probing pocket depth was measured in millimeters from the gingival margin to the base of the sulcus or pocket at six sites per tooth using a Williams periodontal probe.
Measured: Baseline and 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jun 2024
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gingival EnlargementStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İpek Özgü, Akdeniz University
- Investigators
- Nezahat Arzu Kayar, PhD, DDS, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034625
- Sponsor's protocol ID
- AkdenizU1
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Uslu MO, Akgul S. Evaluation of the effects of photobiomodulation therapy and ozone applications after gingivectomy and gingivoplasty on postoperative pain and patients' oral health-related quality of life. Lasers Med Sci. 2020 Sep;35(7):1637-1647. doi: 10.1007/s10103-020-03037-8. Epub 2020 May 20.
PubMed 32435906Reddy SP, Koduganti RR, Panthula VR, Surya Prasanna J, Gireddy H, Dasari R, Ambati M, Chandra G B. Efficacy of Low-level Laser Therapy, Hyaluronic Acid Gel, and Herbal Gel as Adjunctive Tools in Gingivectomy Wound Healing: A Randomized Comparative Clinical and Histological Study. Cureus. 2019 Dec 21;11(12):e6438. doi: 10.7759/cureus.6438.
PubMed 31993275Ozcelik O, Cenk Haytac M, Kunin A, Seydaoglu G. Improved wound healing by low-level laser irradiation after gingivectomy operations: a controlled clinical pilot study. J Clin Periodontol. 2008 Mar;35(3):250-4. doi: 10.1111/j.1600-051X.2007.01194.x.
PubMed 18269665Yakout 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 37891549Kayar NA, Ozgu I, Koksel Babun F, Cohadar Kaya A, Ozel D, Bolat Gumus E, Hatipoglu M. Comparative evaluation of hyaluronic acid spray and low-level laser therapy on wound healing following gingivectomy: a randomized controlled clinical trial. Lasers Med Sci. 2026 Oct 17;41(1):263. doi: 10.1007/s10103-026-05069-y.
PubMed 42888275
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Hyaluronic Acid Spray and Low-Level Laser Therapy on Wound Healing Following Gingivectomy
- ClinicalTrials.gov ID
- NCT07034625
- Acronym / sponsor ID
- AkdenizU1
- Conditions
- Gingival Enlargement
- Keywords
- low-level laser therapy, gingivectomy, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 24 Jun 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.
Gingival enlargement may impair oral hygiene, esthetics, and periodontal health, and gingivectomy is commonly performed when non-surgical treatment is insufficient. Because gingivectomy wounds heal by secondary intention, postoperative wound healing and pain control are clinically important. Low-level laser therapy and hyaluronic acid are adjunctive approaches that may support tissue healing through different biological mechanisms.
This randomized controlled clinical trial compared the effects of topical 0.04% high-molecular-weight hyaluronic acid spray and low-level laser therapy on early wound healing and postoperative pain following gingivectomy. Sixty-four systemically healthy patients requiring gingivectomy were randomly assigned to receive either hyaluronic acid spray applied twice daily for 7 days or 940-nm diode laser therapy applied on postoperative days 0, 3, 5, and 7. Wound healing was assessed using standardized clinical photographs and digital planimetric analysis at baseline and on postoperative days 3, 7, and 14. Postoperative pain was evaluated using a visual analogue scale, and periodontal parameters were recorded at baseline and 6 weeks.
The study aimed to compare these two adjunctive postoperative wound-management approaches after gingivectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Level Laser Therapy | Active comparator | Other: Low Level Laser TherapyParticipants in this group received low-level laser therapy after gingivectomy. A 940-nm diode laser was applied to the surgical wound area on postoperative days 0, 3, 5, and 7. The laser parameters were 3 W power output, 1.07 W/cm² power density, 2.8 cm² probe spot size, continuous wave mode, 1-mm application distance, and non-contact stationary application for 120 seconds per session. |
| Hyaluronic Acid Spray | Active comparator | Other: Hyaluronic Acid SprayParticipants in this group received topical 0.04% high-molecular-weight hyaluronic acid spray after gingivectomy. Patients were instructed to apply the spray to the surgical wound area twice daily for the first 7 postoperative days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Systemically healthy
- Having chronic inflammatory gingival hyperplasia affecting at least 6 teeth symmetrically in the maxillary or mandibular anterior region with gingivectomy indication
- No usage of any medication affecting periodontal tissues or causing gingival hyperplasia such as antiepileptics, immunosupresors or calcium channel blockers
- No history of periodontitis with attachment and bone loss
Key exclusion criteria (5 listed)
- Having systemic disease
- Pregnancy or breastfeeding
- Smoking
- Inadequate oral hygiene
- Antibiotic usage for the past six months
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 |
|---|---|---|
| Low Level Laser TherapyA 940-nm diode laser was applied to the gingivectomy wound area on postoperative days 0, 3, 5, and 7. The laser parameters were set as follows: 3 W power output, 1.07 W/cm² power density, 2.8 cm² probe spot size, continuous wave mode, 1-mm application distance, and non-contact stationary application. The laser was applied for 120 seconds per session. | Other | Low Level Laser Therapy |
| Hyaluronic Acid SprayParticipants received a 0.04% high-molecular-weight hyaluronic acid spray after gingivectomy. They were instructed to apply the spray to the surgical wound area twice daily for the first 7 postoperative days. | Other | Hyaluronic Acid Spray |
Primary outcome
Wound Healing Percentage
Time frame: Baseline, postoperative day 3, day 7, and day 14
Wound healing was assessed by measuring the surgical wound surface area using standardized clinical photographs and digital planimetric analysis with ImageJ software. At baseline and on postoperative days 3, 7, and 14, the gingivectomy wound area was stained with an erythrosin-based plaque-disclosing agent to identify non-epithelialized or insufficiently keratinized areas. The healing percentage was calculated by comparing the wound area at each postoperative time point with the baseline wound area using the following formula: Healing (%) = [(Baseline wound area - Wound area at time point) / Baseline wound area] × 100.
4 secondary outcomes
Postoperative Pain Score (VAS)
Time frame: Postoperative day 1, day 3, day 7, and day 14
Gingival Index
Time frame: Baseline and 6 weeks postoperatively
Full Mouth Bleeding Score
Time frame: Baseline and 6 weeks postoperatively
Probing Pocket Depth
Time frame: Baseline and 6 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 32435906Uslu MO, Akgul S. Evaluation of the effects of photobiomodulation therapy and ozone applications after gingivectomy and gingivoplasty on postoperative pain and patients' oral health-related quality of life. Lasers Med Sci. 2020 Sep;35(7):1637-1647. doi: 10.1007/s10103-020-03037-8. Epub 2020 May 20.
- Background: PubMed 31993275Reddy SP, Koduganti RR, Panthula VR, Surya Prasanna J, Gireddy H, Dasari R, Ambati M, Chandra G B. Efficacy of Low-level Laser Therapy, Hyaluronic Acid Gel, and Herbal Gel as Adjunctive Tools in Gingivectomy Wound Healing: A Randomized Comparative Clinical and Histological Study. Cureus. 2019 Dec 21;11(12):e6438. doi: 10.7759/cureus.6438.
- Background: PubMed 18269665Ozcelik O, Cenk Haytac M, Kunin A, Seydaoglu G. Improved wound healing by low-level laser irradiation after gingivectomy operations: a controlled clinical pilot study. J Clin Periodontol. 2008 Mar;35(3):250-4. doi: 10.1111/j.1600-051X.2007.01194.x.
- Background: 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.
- Derived from this study: PubMed 42888275Kayar NA, Ozgu I, Koksel Babun F, Cohadar Kaya A, Ozel D, Bolat Gumus E, Hatipoglu M. Comparative evaluation of hyaluronic acid spray and low-level laser therapy on wound healing following gingivectomy: a randomized controlled clinical trial. Lasers Med Sci. 2026 Oct 17;41(1):263. doi: 10.1007/s10103-026-05069-y.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Nezahat Arzu Kayar, PhD, DDS principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy and Hyaluronic Acid Spray in people with Gingival Enlargement, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 11 Jun 2026. 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 Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wound Healing Percentage (time frame: Baseline, postoperative day 3, day 7, and day 14). 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 NCT07034625, which also lists 5 linked publications.
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 11 Jun 2026.