Gingival EnlargementNCT05787912
Efficacy of Hyaluronic Acid Gel and Photobiomodulation on Wound Healing After Surgical Gingivectomy
A study testing Photobiomodulation and Hyaluronic acid after photobiomodulation in people with Gingival Enlargement, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of this study was to evaluate the effect of hyaluronic acid gel after photobiomodulation on the healing of surgical gingivectomy sites 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?
- Photobiomodulation and Hyaluronic acid after photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 10 Feb 2023
- 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
- Chronic inflammatory gingival enlargement grade 2 and 3 according to the gingival overgrowth index by Miller and Damn.
- Adequate amount of keratinized tissue.
- Attachment loss= 0
- Well educated patients as post-operative instructions need to be followed precisely.
Who cannot join
- Patients with history of smoking
- Pregnant women
- Patients with bad oral hygiene
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Hyaluronic Acid Gel and Photobiomodulation on Wound Healing After Surgical Gingivectomy: a Randomized Controlled Clinical Trial
The aim of this study was to evaluate the effect of hyaluronic acid gel after photobiomodulation on the healing of surgical gingivectomy sites
- Conditions
- Gingival Enlargement
- Being tested
- Photobiomodulation, Hyaluronic acid after photobiomodulation
- Keywords
- Surgical gingivectomy, Hyaluronic acid, Photobiomodulation
- Medical subject headings
- Gingival Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
The surgical sites were irradiated with a diode laser (980 nm, 0.2W) only.
Hyaluronic acid after photobiomodulationOther
The surgical sites after gingivectomy were irradiated with a diode laser (980 nm, 0.2W) then covered by 2% Hyaluronic acid gel loaded in a special appliance for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation | Experimental | Not described Receives: Device: Photobiomodulation |
| Hyaluronic acid gel after photobiomodulation | Experimental | Not described Receives: Other: Hyaluronic acid after photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Assessed using Landry's healing index which grades the wound on a scale of 1 (poor) to 5 (excellent)
- Very poor (1): ≥50% of gingiva red, bleeding on palpation, Granulation tissue present, Non-epithelialized incision margin with loss of epithelium beyond the margin.
- Poor (2): ≥50% of gingiva red, bleeding on palpation, Granulation tissue present, Non-epithelialized incision margin with exposed connective tissue
- Good (3): ≥25% and<50% of gingiva red, No bleeding on palpation, no granulation tissue, No exposed connective tissue on the incision margin
- Very good (4): <25% of gingiva red, No bleeding on palpation, no granulation tissue, No exposed connective tissue on the incision margin
- Excellent (5): All tissues are pink, No bleeding on palpation, no granulation tissue, No exposed connective tissue on the incision margin
Measured: up to 21 days
Perceived pain
This was assessed using Visual Analogue Scale (VAS). Patients were instructed to chart their perceptions of pain using VAS ranging from 0-10; where 0 represents no pain/burning sensation and 10 represents severe pain/burning sensation.
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Feb 2022
- Primary completion1 Feb 2023
- Study completion10 Feb 2023
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 EnlargementStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Khalil, Alexandria University
- Investigators
- Basma K Yacout, BDS, Principal investigator, Alexandria UniversityFatma R Kamel, PhD, Study director, Alexandria UniversityMaha A Abou Khadr, PhD, Study director, Alexandria UniversityLamia A Heikal, PhD, Study director, Faculty of Pharmacy, Alexandria UniversityGillan I El-Kimary, PhD, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787912
- Sponsor's protocol ID
- #1
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hyaluronic Acid Gel and Photobiomodulation on Wound Healing After Surgical Gingivectomy: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05787912
- Acronym / sponsor ID
- #1
- Conditions
- Gingival Enlargement
- Keywords
- Surgical gingivectomy, Hyaluronic acid, Photobiomodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 28 Mar 2023 (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 aim of this study was to evaluate the effect of hyaluronic acid gel after photobiomodulation on the healing of surgical gingivectomy sites
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Experimental | Device: Photobiomodulation |
| Hyaluronic acid gel after photobiomodulation | Experimental | Other: Hyaluronic acid after photobiomodulation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chronic inflammatory gingival enlargement grade 2 and 3 according to the gingival overgrowth index by Miller and Damn.
- Adequate amount of keratinized tissue.
- Attachment loss= 0
- Well educated patients as post-operative instructions need to be followed precisely.
Key exclusion criteria (5 listed)
- Patients with history of smoking
- Pregnant women
- Patients with bad oral hygiene
- 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
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 |
|---|---|---|
| PhotobiomodulationThe surgical sites were irradiated with a diode laser (980 nm, 0.2W) only. | Device | Photobiomodulation |
| Hyaluronic acid after photobiomodulationThe surgical sites after gingivectomy were irradiated with a diode laser (980 nm, 0.2W) then covered by 2% Hyaluronic acid gel loaded in a special appliance for each patient. | Other | Hyaluronic acid gel after photobiomodulation |
Primary outcome
Wound healing
Time frame: up to 21 days
Assessed using Landry's healing index which grades the wound on a scale of 1 (poor) to 5 (excellent) * Very poor (1): ≥50% of gingiva red, bleeding on palpation, Granulation tissue present, Non-epithelialized incision margin with loss of epithelium beyond the margin. * Poor (2): ≥50% of gingiva red, bleeding on palpation, Granulation tissue present, Non-epithelialized incision margin with exposed connective tissue * Good (3): ≥25% and<50% of gingiva red, No bleeding on palpation, no granulation tissue, No exposed connective tissue on the incision margin * Very good (4): <25% of gingiva red, No bleeding on palpation, no granulation tissue, No exposed connective tissue on the incision margin * Excellent (5): All tissues are pink, No bleeding on palpation, no granulation tissue, No exposed connective tissue on the incision margin
Perceived pain
Time frame: up to 21 days
This was assessed using Visual Analogue Scale (VAS). Patients were instructed to chart their perceptions of pain using VAS ranging from 0-10; where 0 represents no pain/burning sensation and 10 represents severe pain/burning sensation.
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 28 Mar 2023.
- Derived from this study: 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.
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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.
Basma K Yacout, BDS principal investigator
Alexandria University
Fatma R Kamel, PhD study director
Alexandria University
Maha A Abou Khadr, PhD study director
Alexandria 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 Photobiomodulation and Hyaluronic acid after photobiomodulation in people with Gingival Enlargement, run by Alexandria University 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 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 28 Mar 2023. 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?
Wound healing (time frame: up to 21 days). 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 NCT05787912, 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 28 Mar 2023.