Periodontitis and DiabetesPhase 1NCT06997731
Clinical Efficacy of Local Delivery of Minocycline and Hyaluronan Gel to Treat Periodontitis in Diabetic Patients
A Phase 1 study testing Non -surgical treatment and oral hygiene instruction and Application of minocycline and hyaluronic acid gel. in people with Periodontitis and Diabetes and Periodontitis, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to investigate the local delivery of minocycline gel 2% and 0.2% hyaluronan gel to treat periodontitis in diabetic patients as adjunctive to subgingival instrumentation. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Periodontitis and Diabetes, Periodontitis
- What is being tested?
- Non -surgical treatment and oral hygiene instruction and Application of minocycline and hyaluronic acid gel.
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2023to 1 Feb 2025
- Phase
- Phase 1
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with stage II, grade B periodontitis (Attachment loss 3-4 mm and probing pocket depth ≤ 5mm) in both sides.
- Adult controlled diabetic patients (Glycosylated hemoglobin (HbA1C) in controlled diabetics ≤7%)
- Patients who can maintain good oral hygiene
Who cannot join
- History of systemic diseases other than type II diabetes
- Smoking
- Pregnant or lactating women
- Previous treatment of periodontal diseases in the last six months (People who take anti-inflammatory drugs, antibiotics, or vitamins within the previous 6 month).
- People who use mouth washes regularly ·
- Participation in other clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Delivery of Hyaluronan and Minocycline as an Adjunct to Scaling and Root Planing in the Treatment of Stage 2 Grade B Periodontitis in Diabetic Patients: A Randomize Control Clinical Trial With Clinical and Microbiological Study
The goal of this clinical trial is to investigate the local delivery of minocycline gel 2% and 0.2% hyaluronan gel to treat periodontitis in diabetic patients as adjunctive to subgingival instrumentation. The main question it aims to answer is: Does local use of minocycline gel and hyaluronan gel as an adjunct to SRP have resulted in significant additional improvement in the clinical conditions of stage II grade B periodontitis patients when compared with SRP alone?
Read the detailed description
The aim of the present study was to evaluate the clinical and microbial efficacy of local delivery of minocycline gel 2% and 0.2% hyaluronan gel (Gengigel) as an adjunctive therapy to SRP compared with SRP alone in diabetes mellitus with periodontitis patients. A total of twenty controlled diabetic patients with moderate chronic periodontitis were included in the present study. The selected patients were divided into two groups (group I and group II) and every group was divided according to the split-mouth design into applied and control side. All patients were subjected to conventional periodontal therapy (SRP) except applied side of group II. Moreover, the applied side of each group was subjected to sub gingival delivery of minocycline gel and hyaluronan gel (Gengigel) and control side was subjected to SRP, the patients followed up for three weeks. Clinical parameters used in this study included plaque index (PI), gingival index (GI), Bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment level (CAL). These parameters were measured before starting the treatment and after 3 months post treatment regimen. Sub-gingival plaque samples were taken before starting the treatment and after 1 month of treatment using sterile curette and delivered in a sterile tube containing a suitable transport media and analyzed for isolation of P. intermedia and P. gingivalis. The clinical results of both groups showed statistically significant improvement for both applied and control side which higher in applied side of group I for all clinical parameters and results of microbial evaluation showed that P. intermedia and P. gingivalis count decreased significantly after treatment in both groups especially in applied side of group I. Scaling and root planning (SRP) was effective in improving clinical and microbiological parameters in controlled diabetic patients suffering from stage II grade B periodontitis. Local use of minocycline gel and hyaluronan gel (Gengigel) as an adjunct to SRP has resulted in significant additional improvement in the clinical conditions of stage II grade B periodontitis patients when compared with SRP alone, Minocycline and hyaluronan gel (Gengigel) application results in sufficient reduction in bacterial challenge especially when combined with SRP.
- Conditions
- Periodontitis and Diabetes, Periodontitis
- Being tested
- Non -surgical treatment and oral hygiene instruction, Application of minocycline and hyaluronic acid gel., local application of placebo gel
- Keywords
- minocycline gel, hyaluronan gel, periodontitis, Diabetes mellitus, microbiology, scaling and root palning
- Medical subject headings
- Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non -surgical treatment and oral hygiene instructionProcedure or surgery
Scaling and root planing which involves mechanical removal of sup-gingival calculus and necrotic cementum. Tis will be associated with oral hygiene instruction in the form of twice daily brushing for 2 minutes.
Application of minocycline and hyaluronic acid gel.Drug
application of minocycline and Gengigel® topical gel twice weekly for 3-week 1cc for each.
local application of placebo gelDrug
The placebo gel will be applied in the periodontal pocket twice weekly for 3-week 1cc for each.
| Study group | Role | What they receive |
|---|---|---|
| Scaling and Root Planing with placebo gel | Placebo comparator | Twenty sites received oral hygiene instruction and scaling\& root planning with placebo gel.
* Full mouth scaling and root planning were performed in a single visit using hand instruments (scaler and universal curette). This was followed by application of a placebo gel to each studied site.
* Oral hygiene was performed by twice daily brushing for 2 minutes. Receives: Procedure: Non -surgical treatment and oral hygiene instruction; Drug: local application of placebo gel |
| Scaling& root planning followed by placement of local minocycline and Gengigel® gel | Experimental | Ten patients were treated with scaling\& root planning followed by placement of local minocycline and Gengigel® gel twice weekly for 3-week 1cc for each pocket. Receives: Procedure: Non -surgical treatment and oral hygiene instruction; Drug: Application of minocycline and hyaluronic acid gel. |
| minocycline and Gengigel® gel without scaling and root planing | Experimental | ten patients were treated with minocycline and Gengigel® topical twice weekly for 3 week 1cc for each pocket without scaling \&root planning. Receives: Drug: Application of minocycline and hyaluronic acid gel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth (PPD)
Measured: Probing pocket depth will be recorded at baseline and after 3 months post treatment from the gingival margines to the base of the pocket.
Clinical attachment loss (CAL)
Measured: Clinical attachment level will be recorded at baseline and 3 month post treatment.
Microbiological assessment
Measured: Porphyromonas gingivalis, Prevotella intermedia will be counted in subgingival plaque samples at baseline and after 3 months post-treatment
Secondary outcomes (2)
Plaque Index (PI)
Measured: plaque index will be measured at baseline and 3 months after treatment.
Gingival index (GI)
Measured: Gingival index will be recorded at baseline and after 3 months post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start20 May 2023
- Primary completion1 Jan 2025
- Study completion1 Feb 2025
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 Periodontitis and DiabetesStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Elgendy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997731
- Sponsor's protocol ID
- Kafrelsheikh
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
ElHaddad SA, Alasfar AA, El-Shaglabow SA, Elgendy EA, Zahid MN, Abou-Seedou RM, Alzahrani HG. Local delivery of hyaluronan and minocycline as an adjunct to subgingival instrumentation in the treatment of stage II grade B diabetic periodontitis: a randomized split-mouth clinical and microbiological study. Clin Oral Investig. 2025 Nov 21;29(12):578. doi: 10.1007/s00784-025-06664-z.
PubMed 41269357
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Delivery of Hyaluronan and Minocycline as an Adjunct to Scaling and Root Planing in the Treatment of Stage 2 Grade B Periodontitis in Diabetic Patients: A Randomize Control Clinical Trial With Clinical and Microbiological Study
- ClinicalTrials.gov ID
- NCT06997731
- Acronym / sponsor ID
- Kafrelsheikh
- Conditions
- Periodontitis and Diabetes, Periodontitis
- Keywords
- minocycline gel, hyaluronan gel, periodontitis, Diabetes mellitus, microbiology, scaling and root palning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 30 May 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 investigate the local delivery of minocycline gel 2% and 0.2% hyaluronan gel to treat periodontitis in diabetic patients as adjunctive to subgingival instrumentation. The main question it aims to answer is: Does local use of minocycline gel and hyaluronan gel as an adjunct to SRP have resulted in significant additional improvement in the clinical conditions of stage II grade B periodontitis patients when compared with SRP alone?
Detailed description
The aim of the present study was to evaluate the clinical and microbial efficacy of local delivery of minocycline gel 2% and 0.2% hyaluronan gel (Gengigel) as an adjunctive therapy to SRP compared with SRP alone in diabetes mellitus with periodontitis patients. A total of twenty controlled diabetic patients with moderate chronic periodontitis were included in the present study. The selected patients were divided into two groups (group I and group II) and every group was divided according to the split-mouth design into applied and control side. All patients were subjected to conventional periodontal therapy (SRP) except applied side of group II. Moreover, the applied side of each group was subjected to sub gingival delivery of minocycline gel and hyaluronan gel (Gengigel) and control side was subjected to SRP, the patients followed up for three weeks. Clinical parameters used in this study included plaque index (PI), gingival index (GI), Bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment level (CAL). These parameters were measured before starting the treatment and after 3 months post treatment regimen. Sub-gingival plaque samples were taken before starting the treatment and after 1 month of treatment using sterile curette and delivered in a sterile tube containing a suitable transport media and analyzed for isolation of P. intermedia and P. gingivalis. The clinical results of both groups showed statistically significant improvement for both applied and control side which higher in applied side of group I for all clinical parameters and results of microbial evaluation showed that P. intermedia and P. gingivalis count decreased significantly after treatment in both groups especially in applied side of group I. Scaling and root planning (SRP) was effective in improving clinical and microbiological parameters in controlled diabetic patients suffering from stage II grade B periodontitis. Local use of minocycline gel and hyaluronan gel (Gengigel) as an adjunct to SRP has resulted in significant additional improvement in the clinical conditions of stage II grade B periodontitis patients when compared with SRP alone, Minocycline and hyaluronan gel (Gengigel) application results in sufficient reduction in bacterial challenge especially when combined with SRP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scaling and Root Planing with placebo gel | Placebo comparator | Procedure: Non -surgical treatment and oral hygiene instruction, Drug: local application of placebo gelTwenty sites received oral hygiene instruction and scaling\& root planning with placebo gel. * Full mouth scaling and root planning were performed in a single visit using hand instruments (scaler and universal curette). This was followed by application of a placebo gel to each studied site. * Oral hygiene was performed by twice daily brushing for 2 minutes. |
| Scaling& root planning followed by placement of local minocycline and Gengigel® gel | Experimental | Procedure: Non -surgical treatment and oral hygiene instruction, Drug: Application of minocycline and hyaluronic acid gel.Ten patients were treated with scaling\& root planning followed by placement of local minocycline and Gengigel® gel twice weekly for 3-week 1cc for each pocket. |
| minocycline and Gengigel® gel without scaling and root planing | Experimental | Drug: Application of minocycline and hyaluronic acid gel.ten patients were treated with minocycline and Gengigel® topical twice weekly for 3 week 1cc for each pocket without scaling \&root planning. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with stage II, grade B periodontitis (Attachment loss 3-4 mm and probing pocket depth ≤ 5mm) in both sides.
- Adult controlled diabetic patients (Glycosylated hemoglobin (HbA1C) in controlled diabetics ≤7%)
- Patients who can maintain good oral hygiene
Key exclusion criteria (6 listed)
- History of systemic diseases other than type II diabetes
- Smoking
- Pregnant or lactating women
- Previous treatment of periodontal diseases in the last six months (People who take anti-inflammatory drugs, antibiotics, or vitamins within the previous 6 month).
- People who use mouth washes regularly ·
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 |
|---|---|---|
| Non -surgical treatment and oral hygiene instructionScaling and root planing which involves mechanical removal of sup-gingival calculus and necrotic cementum. Tis will be associated with oral hygiene instruction in the form of twice daily brushing for 2 minutes. | Procedure or surgery | Scaling and Root Planing with placebo gel, Scaling& root planning followed by placement of local minocycline and Gengigel® gel |
| Application of minocycline and hyaluronic acid gel.application of minocycline and Gengigel® topical gel twice weekly for 3-week 1cc for each. | Drug | Scaling& root planning followed by placement of local minocycline and Gengigel® gel, minocycline and Gengigel® gel without scaling and root planing |
| local application of placebo gelThe placebo gel will be applied in the periodontal pocket twice weekly for 3-week 1cc for each. | Drug | Scaling and Root Planing with placebo gel |
Primary outcome
Probing pocket depth (PPD)
Time frame: Probing pocket depth will be recorded at baseline and after 3 months post treatment from the gingival margines to the base of the pocket.
Clinical attachment loss (CAL)
Time frame: Clinical attachment level will be recorded at baseline and 3 month post treatment.
Microbiological assessment
Time frame: Porphyromonas gingivalis, Prevotella intermedia will be counted in subgingival plaque samples at baseline and after 3 months post-treatment
2 secondary outcomes
Plaque Index (PI)
Time frame: plaque index will be measured at baseline and 3 months after treatment.
Gingival index (GI)
Time frame: Gingival index will be recorded at baseline and after 3 months post treatment.
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 30 May 2025.
- Derived from this study: PubMed 41269357ElHaddad SA, Alasfar AA, El-Shaglabow SA, Elgendy EA, Zahid MN, Abou-Seedou RM, Alzahrani HG. Local delivery of hyaluronan and minocycline as an adjunct to subgingival instrumentation in the treatment of stage II grade B diabetic periodontitis: a randomized split-mouth clinical and microbiological study. Clin Oral Investig. 2025 Nov 21;29(12):578. doi: 10.1007/s00784-025-06664-z.
- 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. 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 Phase 1 study testing Non -surgical treatment and oral hygiene instruction and Application of minocycline and hyaluronic acid gel. in people with Periodontitis and Diabetes and Periodontitis, run by Kafrelsheikh 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 3 inclusion and 6 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 30 May 2025. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Probing pocket depth (PPD) (time frame: Probing pocket depth will be recorded at baseline and after 3 months post treatment from the gingival margines to the base of the pocket.). 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?
On the ClinicalTrials.gov record for NCT06997731, 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 30 May 2025.