Gingival EnlargementNCT07234994
Comparison of the Effect of Ozonized Gel to That of Photobiomodulation Therapy on Wound Healing Following Surgical Gingivectomy
A study testing ozonized gel application and photobiomodulation therapy using diode laser in people with Gingival Enlargement, run by Mennatullah osama ahmed zaki wahba at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the effect of photobiomodulation to ozonized gel on wound healing following gingivectomy procedure on adults. The main questions it aims to answer are: Which treatment modality provides less painful and more efficient wound healing ? What are the patient's feedback on… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Gingival Enlargement
- What is being tested?
- ozonized gel application and photobiomodulation therapy using diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Nov 2025to 30 Mar 2026
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients indicated for surgical gingivectomy.
- Adequate amount of keratinized tissue.
- Average age between 18-40 years.
- Well-educated patients as post-operative instructions need to be followed precisely.
- Good oral hygiene with a full mouth O'Leary plaque index of less than or equal to 10% and a full mouth Gingival Index of zero
Who cannot join
- History of smoking.
- Patients who have any known systemic disease that interfere with performance of surgical gingivectomy or periodontal wound healing.
- Patients who have any previous adverse reactions to the products (or similar products) used in this study.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ozonized Gel Compared to Photobiomodulation Therapy on Wound Healing Following Surgical Gingivectomy : A Randomized Controlled Clinical Trial
The goal of this clinical trial is to compare the effect of photobiomodulation to ozonized gel on wound healing following gingivectomy procedure on adults. The main questions it aims to answer are:
Which treatment modality provides less painful and more efficient wound healing ? What are the patient's feedback on different treatment modalities ? Researchers will compare ozonized gel to photobiomodulation to normal gingivectomy procedure with no interference.
Participants will:
Receive either ozonized gel or photobiomodualtion treatment following surgical gingivectomy Visit the clinic every 3,7,14 and 28 days for checkups and investigations
Read the detailed description
Surgical gingivectomy is performed for elimination of supra bony pockets and gingival enlargements and it can be considered the gold standard treatment for such cases. The healing of wound site after gingivectomy occurs slowly by secondary intention; therefore, several studies have been conducted evaluating the effect of various treatment modalities to accelerate the process of wound healing such as use of ozonized gel and photobiomodulation. Ozone, owing to its biocompatibility, healing, and antimicrobial properties, is used for wound healing and tissue repair. Photobiomodulation Therapy (PBMT) using diode laser is another treatment modality regarded as an effective modality for the repair of tissues, control of pain and wound healing. This study will be carried out to clinically compare and evaluate the healing of surgical gingivectomy wounds using ozonized gel and PBMT.
Aim: Compare the efficacy of the ozonized gel to photobiomodulation therapy in wound healing following surgical gingivectomy Materials and Methods: This randomized controlled clinical trial will involve 48 surgical gingivectomy wound sites, equally divided into three groups, Group-I (test group1): ozonized hydrogel will be applied to raw wound area following surgical gingivectomy and at days 3,7,14 post surgery. Group II (test group 2): the surgical site will be irradiated with a diode laser (635 nm) directly following surgery and at days 3,7,14 postoperative. Group III (control group) will include surgical gingivectomies that will be left to heal spontaneously. Wound healing will be assessed using Landry's Healing index and by measuring degree of epithelialization, and pain level will be assessed using a Visual analog scale on the 3rd, 7th, 14th, and 28th days after surgery.
- Conditions
- Gingival Enlargement
- Being tested
- ozonized gel application, photobiomodulation therapy using diode laser
- Keywords
- Ozonized gel, Photobiomodulation Therapy, Surgical gingivectomy, Wound healing
- Medical subject headings
- Gingival Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozonized gel applicationDrug
Application of ozonized gel to raw wound area following surgical gingivectomy.
photobiomodulation therapy using diode laserDevice
Application of diode laser 635nm to wound area following surgical gingivectomy
| Study group | Role | What they receive |
|---|---|---|
| Ozonized gel group | Active comparator | Application of ozonized gel to raw wound area following surgical gingivectomy. Receives: Drug: ozonized gel application |
| Photobiomodulation therapy group | Active comparator | Application of diode laser 635nm to wound area following surgical gingivectomy Receives: Device: photobiomodulation therapy using diode laser |
| Control group | No intervention | Spontaneous healing of wound area following surgical gingivectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing index (HI) using Landry index
The healing index (HI) scores will be assessed on the basis of redness, presence of granulation tissues, bleeding, suppuration, and epithelialization.
Measured: day 3,7,14,28 post surgical gingivectomy
Evaluation of epithelialization of the wound area
A plaque disclosing agent is used to measure wound area epithelialization by dying the abraded and deepithelialized areas on the gingiva on postoperative days 3,7,14 and 28. By using this solution, assessment of degree of epithelialization and wound healing is made easier. Wound surface epithelialization in the obtaining photographs will be evaluated using an Image-analyzing software. To ensure standardization, all photographs will taken by the same person with the same camera at the same angle.
Measured: days 0,3,7,14,28 post surgical gingivectomy
Postoperative pain using the VAS
Visual Analogue Scale (VAS) is a simple measurement tool that measures the intensity of pain as recorded by the patient. 10-point visual analog scale of pain rating, with 0 marked as "no pain" and 10 marked as "worst pain imaginable
Measured: day 0. day 3, day 7, and day 14 post surgery.
Secondary outcomes (1)
Gingival crevicular fluid sampling for Vascular Endothelial Growth Factor quantification
Vascular Endothelial Growth Factor (VEGF) was analyzed from gingival crevicular fluid (GCF) at baseline, days 7, 14, and 28 for biochemical analysis using ELISA kit.
Measured: baseline(day 0), day 7,day14 and day 28 post gingivectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start16 Nov 2025
- Primary completion15 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival EnlargementStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mennatullah osama ahmed zaki wahba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mennatullah osama ahmed zaki wahba, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234994
- Sponsor's protocol ID
- 9245845
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ozonized Gel Compared to Photobiomodulation Therapy on Wound Healing Following Surgical Gingivectomy : A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07234994
- Acronym / sponsor ID
- 9245845
- Conditions
- Gingival Enlargement
- Keywords
- Ozonized gel, Photobiomodulation Therapy, Surgical gingivectomy, Wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mennatullah osama ahmed zaki wahbaUniversity, hospital or other
- Study start
- 16 Nov 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 19 Nov 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.
The goal of this clinical trial is to compare the effect of photobiomodulation to ozonized gel on wound healing following gingivectomy procedure on adults. The main questions it aims to answer are:
Which treatment modality provides less painful and more efficient wound healing ? What are the patient's feedback on different treatment modalities ? Researchers will compare ozonized gel to photobiomodulation to normal gingivectomy procedure with no interference.
Participants will:
Receive either ozonized gel or photobiomodualtion treatment following surgical gingivectomy Visit the clinic every 3,7,14 and 28 days for checkups and investigations
Detailed description
Surgical gingivectomy is performed for elimination of supra bony pockets and gingival enlargements and it can be considered the gold standard treatment for such cases. The healing of wound site after gingivectomy occurs slowly by secondary intention; therefore, several studies have been conducted evaluating the effect of various treatment modalities to accelerate the process of wound healing such as use of ozonized gel and photobiomodulation. Ozone, owing to its biocompatibility, healing, and antimicrobial properties, is used for wound healing and tissue repair. Photobiomodulation Therapy (PBMT) using diode laser is another treatment modality regarded as an effective modality for the repair of tissues, control of pain and wound healing. This study will be carried out to clinically compare and evaluate the healing of surgical gingivectomy wounds using ozonized gel and PBMT.
Aim: Compare the efficacy of the ozonized gel to photobiomodulation therapy in wound healing following surgical gingivectomy Materials and Methods: This randomized controlled clinical trial will involve 48 surgical gingivectomy wound sites, equally divided into three groups, Group-I (test group1): ozonized hydrogel will be applied to raw wound area following surgical gingivectomy and at days 3,7,14 post surgery. Group II (test group 2): the surgical site will be irradiated with a diode laser (635 nm) directly following surgery and at days 3,7,14 postoperative. Group III (control group) will include surgical gingivectomies that will be left to heal spontaneously. Wound healing will be assessed using Landry's Healing index and by measuring degree of epithelialization, and pain level will be assessed using a Visual analog scale on the 3rd, 7th, 14th, and 28th days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ozonized gel group | Active comparator | Drug: ozonized gel applicationApplication of ozonized gel to raw wound area following surgical gingivectomy. |
| Photobiomodulation therapy group | Active comparator | Device: photobiomodulation therapy using diode laserApplication of diode laser 635nm to wound area following surgical gingivectomy |
| Control group | No intervention | –Spontaneous healing of wound area following surgical gingivectomy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients indicated for surgical gingivectomy.
- Adequate amount of keratinized tissue.
- Average age between 18-40 years.
- Well-educated patients as post-operative instructions need to be followed precisely.
- Good oral hygiene with a full mouth O'Leary plaque index of less than or equal to 10% and a full mouth Gingival Index of zero
Key exclusion criteria (4 listed)
- History of smoking.
- Patients who have any known systemic disease that interfere with performance of surgical gingivectomy or periodontal wound healing.
- Patients who have any previous adverse reactions to the products (or similar products) used in this study.
- Pregnant women.
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 |
|---|---|---|
| ozonized gel applicationApplication of ozonized gel to raw wound area following surgical gingivectomy. | Drug | Ozonized gel group |
| photobiomodulation therapy using diode laserApplication of diode laser 635nm to wound area following surgical gingivectomy | Device | Photobiomodulation therapy group |
Primary outcome
Healing index (HI) using Landry index
Time frame: day 3,7,14,28 post surgical gingivectomy
The healing index (HI) scores will be assessed on the basis of redness, presence of granulation tissues, bleeding, suppuration, and epithelialization.
Evaluation of epithelialization of the wound area
Time frame: days 0,3,7,14,28 post surgical gingivectomy
A plaque disclosing agent is used to measure wound area epithelialization by dying the abraded and deepithelialized areas on the gingiva on postoperative days 3,7,14 and 28. By using this solution, assessment of degree of epithelialization and wound healing is made easier. Wound surface epithelialization in the obtaining photographs will be evaluated using an Image-analyzing software. To ensure standardization, all photographs will taken by the same person with the same camera at the same angle.
Postoperative pain using the VAS
Time frame: day 0. day 3, day 7, and day 14 post surgery.
Visual Analogue Scale (VAS) is a simple measurement tool that measures the intensity of pain as recorded by the patient. 10-point visual analog scale of pain rating, with 0 marked as "no pain" and 10 marked as "worst pain imaginable
1 secondary outcome
Gingival crevicular fluid sampling for Vascular Endothelial Growth Factor quantification
Time frame: baseline(day 0), day 7,day14 and day 28 post gingivectomy
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 22 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ozonized gel application and photobiomodulation therapy using diode laser in people with Gingival Enlargement, run by Mennatullah osama ahmed zaki wahba at 1 site in Egypt.
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 5 inclusion and 4 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 22 May 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 Egypt. 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?
Healing index (HI) using Landry index (time frame: day 3,7,14,28 post surgical gingivectomy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.