Treatment of Stage III PeriodontitisEarly Phase 1NCT07746206
Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis
A Early Phase 1 study testing Insulin, Hyaluronic acid gel and mechanical debridement in people with Treatment of Stage III Periodontitis and Local Application of Insulin in Pockets, run by Doaa Atta Aid at 2 sites in Egypt.
Trial summary
The present study will be performed on fourty-five patients suffering from periodontitis according to the criteria of American academy of periodontology to evaluate clinically effect of topical application of insulin versus hyaluronic acid as an adjunct to non surgical periodontal therapy in stage Ⅲ periodontitis… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Treatment of Stage III Periodontitis, Local Application of Insulin in Pockets
- What is being tested?
- Insulin, Hyaluronic acid gel and mechanical debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesEgypt
- Study dates
- 24 Jul 2026to 25 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All selected patients are free from systemic illness as evaluated according to dental modification of the Cornell medical index.
- Should be diagnosed as having periodontitis.
- Not received any type of periodontal treatment in the past 6 months prior to examination.
- Should be cooperative, motivated, and willing to follow our treatment protocol and follow up visits.
- Not received antibiotics or anti-inflammatory therapy in the 6 months prior to examination.
Who cannot join
- Antibiotic therapy in the preceding 6 months or during study participation.
- History of insulin dependent diabetes and thyroid disease.
- Pregnancy, smoking, chronic diseases such as diabetes mellitus or rheumatoid arthritis, and allergy to ingredients in the drug.
- Poor oral hygiene compliance or inability to adhere to the clinical protocol.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Alazhar university
Cairo
Doaa Abdelrazik, BDS, 00201012430093 ext. 00201012430093, duaaabdelrazik@gmail.com
- Recruiting
Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo
Doaa Abdelrazik, BDS, 00201012430093, duaaabdelrazik@gmail.com
About this study
Official title: Evaluation of Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis Patients: A Randomized Controlled Clinical Trial
The present study will be performed on fourty-five patients suffering from periodontitis according to the criteria of American academy of periodontology to evaluate clinically effect of topical application of insulin versus hyaluronic acid as an adjunct to non surgical periodontal therapy in stage Ⅲ periodontitis patients.
This will be done by:
Read more
- Clinical assessment.
- Biochemical analysis. - Dose the topical application of insulin or hyaluronic acid as an adjunct to non-surgical periodontal therapy improves periodontal condition in stage Ⅲ periodontitis patients? PICO P (Population): patients with stage Ⅲ periodontitis. I (Intervention): non surgical periodontal therapy (SRP) with topical application using insulin or hyaluronic acid in periodontal pockets.
C (Comparison): topical application of insulin versus hyaluronic acid and SRP alone in periodontal pocket.
O (Outcome): primary outcome: change in periodontal pocket depth (PPD) or clinical attachment loss (CAL). Secondary outcome: change in gingival index (GI) or bleeding on probing index (BOP) and levels of IL-1β in GCF of treated pocket.
Study type: Randomized controlled trials (RCTs).
Read the detailed description
The design of this clinical trial will be randomized double blind technique; the randomization of the patients will be performed through a computer program.
The randomization of patients will form the following 3 groups:
Group (Ⅰ): control group including (15) stage Ⅲ periodontitis patients who will receive scaling and root planning (SRP) alone.
Group (Ⅱ): including (15) stage Ⅲ periodontitis patients who will receive topical application of insulin adjunct to SRP.
Group (Ⅲ): including (15) stage Ⅲ periodontitis patients who will receive topical application of hyaluronic acid adjunct to SRP.
- Being tested
- Insulin, Hyaluronic acid gel, mechanical debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
subgingival scaling and root planning with topical application of insulin gel into periodontal pockets after scaling and root planing.tion of insulin
Hyaluronic acid gelDrug
Topical application of hyaluronic acid gel into periodontal pockets after scaling and root planing.
mechanical debridementProcedure or surgery
sub gingival scaling and root planning of periodontal pockets
| Study group | Role | What they receive |
|---|---|---|
| scaling and root planning and topical insulin for stage Ⅲ periodontitis patients | Active comparator | Participants receive scaling and root planing followed by topical application of insulin gel into periodontal pockets. Receives: Drug: Insulin |
| scaling and root planning with topical application of hyaluronic acid gel | Experimental | Participants receive scaling and root planing followed by topical application of hyaluronic acid gel into periodontal pockets. Receives: Drug: Hyaluronic acid gel |
| Stage III periodontitis patients | Active comparator | patients have stage III periodontitis Receives: Procedure: mechanical debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal pocket depth (PPD)
(PD) measured in (mm) from free gingival margin to the base of the pocket at six sites per tooth (mesiobuccal and mesiolingual, distobuccal and distolingual, and mid-buccal and mid-lingual regions).
Measured: 3-6 months
Clinical attachment loss (CAL)
(CAL) measured in(mm)from the cemento-enamel junction (CEJ) to the base of the pocket at the same previous six sites per tooth.
Measured: 3-6 months
Secondary outcomes (3)
Change in gingival index (GI)
(GI) index measured at 4 sites per tooth (buccal, mesial, distal, and lingual).
Measured: 3-6 months follow up
Change in bleeding on probing index (BOP)
(BOP) determined by the presence or absence of bleeding (with in15 sec.) after periodontal probing.
Measured: 3-6 months follow up
Change in levels of IL-1β in gingival crevicular fluid (GCF) of treated pocket
Using the Bioassay Technology Laboratory IL-1β ELISA kit to determine levels of IL-1β in (GCF) using enzyme-linked immunosorbent assay (ELISA).
Measured: 3-6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start24 Jul 2026
- Primary completion25 Jul 2026
- Study completion25 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Stage III PeriodontitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Doaa Atta Aid
- Sponsor type
- Other government
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor-investigator, Doaa Atta Aid, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746206
- Sponsor's protocol ID
- OMPDR-105-2K
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07746206
- Acronym / sponsor ID
- OMPDR-105-2K
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Doaa Atta AidOther government
- Collaborators
- Al-Azhar University
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- 25 Jul 2026 (actual)
- Study completion
- 25 Jul 2026 (estimated)
- First posted
- 4 Aug 2026 (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 present study will be performed on fourty-five patients suffering from periodontitis according to the criteria of American academy of periodontology to evaluate clinically effect of topical application of insulin versus hyaluronic acid as an adjunct to non surgical periodontal therapy in stage Ⅲ periodontitis patients.
This will be done by:
- Clinical assessment.
- Biochemical analysis. - Dose the topical application of insulin or hyaluronic acid as an adjunct to non-surgical periodontal therapy improves periodontal condition in stage Ⅲ periodontitis patients? PICO P (Population): patients with stage Ⅲ periodontitis. I (Intervention): non surgical periodontal therapy (SRP) with topical application using insulin or hyaluronic acid in periodontal pockets.
C (Comparison): topical application of insulin versus hyaluronic acid and SRP alone in periodontal pocket.
O (Outcome): primary outcome: change in periodontal pocket depth (PPD) or clinical attachment loss (CAL). Secondary outcome: change in gingival index (GI) or bleeding on probing index (BOP) and levels of IL-1β in GCF of treated pocket.
Study type: Randomized controlled trials (RCTs).
Detailed description
The design of this clinical trial will be randomized double blind technique; the randomization of the patients will be performed through a computer program.
The randomization of patients will form the following 3 groups:
Group (Ⅰ): control group including (15) stage Ⅲ periodontitis patients who will receive scaling and root planning (SRP) alone.
Group (Ⅱ): including (15) stage Ⅲ periodontitis patients who will receive topical application of insulin adjunct to SRP.
Group (Ⅲ): including (15) stage Ⅲ periodontitis patients who will receive topical application of hyaluronic acid adjunct to SRP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| scaling and root planning and topical insulin for stage Ⅲ periodontitis patients | Active comparator | Drug: InsulinParticipants receive scaling and root planing followed by topical application of insulin gel into periodontal pockets. |
| scaling and root planning with topical application of hyaluronic acid gel | Experimental | Drug: Hyaluronic acid gelParticipants receive scaling and root planing followed by topical application of hyaluronic acid gel into periodontal pockets. |
| Stage III periodontitis patients | Active comparator | Procedure: mechanical debridementpatients have stage III periodontitis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- All selected patients are free from systemic illness as evaluated according to dental modification of the Cornell medical index.
- Should be diagnosed as having periodontitis.
- Not received any type of periodontal treatment in the past 6 months prior to examination.
- Should be cooperative, motivated, and willing to follow our treatment protocol and follow up visits.
- Not received antibiotics or anti-inflammatory therapy in the 6 months prior to examination.
Key exclusion criteria (4 listed)
- Antibiotic therapy in the preceding 6 months or during study participation.
- History of insulin dependent diabetes and thyroid disease.
- Pregnancy, smoking, chronic diseases such as diabetes mellitus or rheumatoid arthritis, and allergy to ingredients in the drug.
- Poor oral hygiene compliance or inability to adhere to the clinical protocol.
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 |
|---|---|---|
| Insulinsubgingival scaling and root planning with topical application of insulin gel into periodontal pockets after scaling and root planing.tion of insulin | Drug | scaling and root planning and topical insulin for stage Ⅲ periodontitis patients |
| Hyaluronic acid gelTopical application of hyaluronic acid gel into periodontal pockets after scaling and root planing. | Drug | scaling and root planning with topical application of hyaluronic acid gel |
| mechanical debridementsub gingival scaling and root planning of periodontal pockets | Procedure or surgery | Stage III periodontitis patients |
Primary outcome
Periodontal pocket depth (PPD)
Time frame: 3-6 months
(PD) measured in (mm) from free gingival margin to the base of the pocket at six sites per tooth (mesiobuccal and mesiolingual, distobuccal and distolingual, and mid-buccal and mid-lingual regions).
Clinical attachment loss (CAL)
Time frame: 3-6 months
(CAL) measured in(mm)from the cemento-enamel junction (CEJ) to the base of the pocket at the same previous six sites per tooth.
3 secondary outcomes
Change in gingival index (GI)
Time frame: 3-6 months follow up
Change in bleeding on probing index (BOP)
Time frame: 3-6 months follow up
Change in levels of IL-1β in gingival crevicular fluid (GCF) of treated pocket
Time frame: 3-6 months follow up
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 4 Aug 2026.
- Individual participant dataSharing planned: Yes
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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.
Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo, Egypt
2 sites 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 Insulin, Hyaluronic acid gel and mechanical debridement in people with Treatment of Stage III Periodontitis and Local Application of Insulin in Pockets, run by Doaa Atta Aid at 2 sites 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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal pocket depth (PPD) (time frame: 3-6 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?
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 4 Aug 2026.