Periodontal DiseasesNCT05543434
Application of Hyaluronic Acid in Diabetes
A study testing Hyaluronic acid in people with Periodontal Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
sub gingival application of hyaluronic acid create great clinical improvement of periodontal pocket treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Hyaluronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 Dec 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 years.
- Patient with controlled diabetic type 2 (HgA1C <7) (Mori et al., 2021).
- Periodontitis stage II.
- Periodontitis grade B.
- Pocket depth > 4 mm.
- Smoking ≤ 10 cigarettes/day.
- Cooperative patients able and accept to come for follow up appointments
Who cannot join
- • The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up.
- Having surgical therapy or undergoing orthodontic treatment.
- Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
- Pregnant and lactation females.
- Smoking ˃ 10 cigarettes/day.
- Patients with poor oral hygiene.
- Any known allergies
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of dentistry Cairo university
Cairo, 12311
Nesma M Shemais, PHD, 00201005615697, nesma.shemais@dentistry.cu.edu.eg
About this study
Official title: Evaluation of The Clinical & Radiographic Parameters in Controlled Type 2 Diabetic Patients Treated With Non-Surgical Periodontal Therapy With & Without Using Hyaluronic Acid Gel
sub gingival application of hyaluronic acid create great clinical improvement of periodontal pocket treatment.
Read the detailed description
To clinically and radiographically evaluate the adjunctive effect of the local application of a 0.8% hyaluronan gel in addition to scaling and root planing in treatment of controlled diabetic patients with stage II periodontitis.
- Conditions
- Periodontal Diseases
- Being tested
- Hyaluronic acid
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDrug
Also called Gingigel /Germany
anti-inflammatory, anti-edematous, osseoinductive.
| Study group | Role | What they receive |
|---|---|---|
| hyaluronic acid | Experimental | Application of crosslinked HA gel in pockets after subgingival debridement immediately and one week after. Receives: Drug: Hyaluronic acid |
| scaling and root planing | Active comparator | scaling and root planing using ultrasonic scaler and hand instruments. Receives: Drug: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level gain
Clinical attachment gain by using UNC15 Periodontal probe/ numerical data
Measured: 3 months
Secondary outcomes (4)
Pocket depth reduction
Pocket depth reduction by using UNC15 Periodontal probe/ numerical data
Measured: 3 moths
Bleeding on probing
Bleeding on probing by using UNC15 Periodontal probe/ binary data
Measured: 3 months
Gingival Recession
Gingival Recession by using UNC15 Periodontal probe/ numerical data
Measured: 3 months
Radiographic Evaluation
by using periapical radiograph with standardized acrylic stent
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Dec 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.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Mohammed Ahmed Al-abbadi, Cairo University
- Investigators
- Reem M Alabbadi, BDS, Principal investigator, master studentNesma M Shemais, PHD, Study director, Lecturer of Oral Medicine and Periodontology- faculty of dentistry/Cairo UniversityKarim F Elsayed, professor, Study chair, Associate Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543434
- Sponsor's protocol ID
- Reem
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Abbadi R, Shemais N, Nawwar A, Fawzy El-Sayed KM. Non-surgical periodontal therapy with and without hyaluronic acid gel in type 2 diabetic stage-II periodontitis patients: a randomized clinical trial. BMC Oral Health. 2025 Jul 15;25(1):1166. doi: 10.1186/s12903-025-06485-2.
PubMed 40665270
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Clinical & Radiographic Parameters in Controlled Type 2 Diabetic Patients Treated With Non-Surgical Periodontal Therapy With & Without Using Hyaluronic Acid Gel
- ClinicalTrials.gov ID
- NCT05543434
- Acronym / sponsor ID
- Reem
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 16 Sep 2022 (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.
sub gingival application of hyaluronic acid create great clinical improvement of periodontal pocket treatment.
Detailed description
To clinically and radiographically evaluate the adjunctive effect of the local application of a 0.8% hyaluronan gel in addition to scaling and root planing in treatment of controlled diabetic patients with stage II periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyaluronic acid | Experimental | Drug: Hyaluronic acidApplication of crosslinked HA gel in pockets after subgingival debridement immediately and one week after. |
| scaling and root planing | Active comparator | Drug: Hyaluronic acidscaling and root planing using ultrasonic scaler and hand instruments. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Patient with controlled diabetic type 2 (HgA1C <7) (Mori et al., 2021).
- Periodontitis stage II.
- Periodontitis grade B.
- Pocket depth > 4 mm.
Key exclusion criteria (7 listed)
- • The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up.
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 |
|---|---|---|
| Hyaluronic acidAlso: Gingigel /Germanyanti-inflammatory, anti-edematous, osseoinductive. | Drug | hyaluronic acid, scaling and root planing |
Primary outcome
Clinical attachment level gain
Time frame: 3 months
Clinical attachment gain by using UNC15 Periodontal probe/ numerical data
4 secondary outcomes
Pocket depth reduction
Time frame: 3 moths
Bleeding on probing
Time frame: 3 months
Gingival Recession
Time frame: 3 months
Radiographic Evaluation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 40665270Al-Abbadi R, Shemais N, Nawwar A, Fawzy El-Sayed KM. Non-surgical periodontal therapy with and without hyaluronic acid gel in type 2 diabetic stage-II periodontitis patients: a randomized clinical trial. BMC Oral Health. 2025 Jul 15;25(1):1166. doi: 10.1186/s12903-025-06485-2.
- 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.
Reem M Alabbadi, BDS principal investigator
master student
Nesma M Shemais, PHD study director
Lecturer of Oral Medicine and Periodontology- faculty of dentistry/Cairo University
Karim F Elsayed, professor study chair
Associate Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo 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 Hyaluronic acid in people with Periodontal Diseases, run by Cairo 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 7 inclusion and 7 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 21 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reem M Alabbadi, BDS (00201551563633, reem.alabbadi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment level gain (time frame: 3 months). 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 NCT05543434, 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 21 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.