Periodontal DiseasesPhase 3NCT05746676
Insulin Versus Hyaluronic Acid in Management of Periodontal Defects
A Phase 3 study testing Insulin and Hyaluronic acid in people with Periodontal Diseases and Periodontal Pocket, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
in this study, insulin and hyaluronic acid will be used after open flap debridement in treatment of periodontal defects. outcome will be evaluated clinically and radiographically Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontal Pocket
- What is being tested?
- Insulin and Hyaluronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2023to Oct 2023
- Phase
- Phase 3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients diagnosed with periodontitis
Who cannot join
- patients with systemic illness that contraindicate periodontal surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University, Faculty of Dentistry
Cairo
Inas Motawe, prof, 01010112121
About this study
Official title: Clinical and Radiographic Evaluation of Insulin Versus Hyaluronic Acid in Management of Periodontal Defects
in this study, insulin and hyaluronic acid will be used after open flap debridement in treatment of periodontal defects. outcome will be evaluated clinically and radiographically
Read the detailed description
n this study, insulin versus hyaluronic acid will be used after open flap debridement in treatment of periodontal defects. outcome will be evaluated clinically and radiographically after a follow up period
- Conditions
- Periodontal Diseases, Periodontal Pocket
- Being tested
- Insulin, Hyaluronic acid
- Keywords
- periodontitis, insulin, regeneration
- Medical subject headings
- Periodontal Diseases, Periodontal Pocket, Periodontitis, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
in treatment of periodontal defects
Hyaluronic acidDrug
in treatment of periodontal defects
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | Not described Receives: Drug: Insulin |
| group 2 | Active comparator | Not described Receives: Drug: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical evaluation
periodontal pocket depth
Measured: 6 months
radiographic evaluation
bone gain assessed by cone beam computed tomography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start12 Jan 2023
- Primary completionAug 2023 (estimated)
- Study completionOct 2023 (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 Periodontal DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Elwakeel, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746676
- Sponsor's protocol ID
- P-ME-23-01
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
El-Wakeel N, Abdelgawad N, Nour Eldien M. Clinical and radiographic evaluation of local application of insulin versus hyaluronic acid using resorbable collagen sponge in management of periodontal intra-bony defects: a pilot randomized controlled clinical trial. Clin Oral Investig. 2026 Jul 20;30(8):350. doi: 10.1007/s00784-026-07015-2.
PubMed 42474735
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Insulin Versus Hyaluronic Acid in Management of Periodontal Defects
- ClinicalTrials.gov ID
- NCT05746676
- Acronym / sponsor ID
- P-ME-23-01
- Conditions
- Periodontal Diseases, Periodontal Pocket
- Keywords
- periodontitis, insulin, regeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 28 Feb 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.
in this study, insulin and hyaluronic acid will be used after open flap debridement in treatment of periodontal defects. outcome will be evaluated clinically and radiographically
Detailed description
n this study, insulin versus hyaluronic acid will be used after open flap debridement in treatment of periodontal defects. outcome will be evaluated clinically and radiographically after a follow up period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Drug: Insulin |
| group 2 | Active comparator | Drug: Hyaluronic acid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed with periodontitis
Key exclusion criteria (1 listed)
- patients with systemic illness that contraindicate periodontal surgery
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 |
|---|---|---|
| Insulinin treatment of periodontal defects | Drug | group 1 |
| Hyaluronic acidin treatment of periodontal defects | Drug | group 2 |
Primary outcome
clinical evaluation
Time frame: 6 months
periodontal pocket depth
radiographic evaluation
Time frame: 6 months
bone gain assessed by cone beam computed tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 42474735El-Wakeel N, Abdelgawad N, Nour Eldien M. Clinical and radiographic evaluation of local application of insulin versus hyaluronic acid using resorbable collagen sponge in management of periodontal intra-bony defects: a pilot randomized controlled clinical trial. Clin Oral Investig. 2026 Jul 20;30(8):350. doi: 10.1007/s00784-026-07015-2.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin and Hyaluronic acid in people with Periodontal Diseases and Periodontal Pocket, run by October University for Modern Sciences and Arts 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Feb 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naglaa El-Wakeel, Prof. (+2 01001757761, naglaelwakeel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical evaluation (time frame: 6 months). 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 NCT05746676, 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 Feb 2023.