PeriodontitisNCT05682833
Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis
A study testing Non surgical periodontal therapy in people with Periodontitis and Hyaluronic Acid, run by University of Sharjah at 1 site in United Arab Emirates.
Trial summary
General Objective : To evaluate the outcome of non surgical periodontal therapy with local drug delivery adjunct to scaling and root planning Specific Objective : To determine the effect of intra-pocket application of hyaluronic acid /chlorohexidine gel in non surgical periodontal treatment on clinical periodontal… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Hyaluronic Acid, Chlorhexidine
- What is being tested?
- Non surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Oct 2022to 20 Jun 2024
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age : 20-60 years old
- At least 20 remaining teeth
- Periodontitis stage III and IV ,Grade A, B and C
Who cannot join
- Patients taking specific medications: antibiotic , anticoagulants or anti-inflammatory
- Previous periodontal therapy in the past 3-6 months.
- Immunocompromised patients
- Systemically diseased patients: Diabetes ,osteoporosis etc
- History of allergies or hypersensitivity reactions to chlorohexidine or Hyaluronic acid
- Pregnant or lactating women.
- Heavy Smokers (more than 20/day)
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
University Dental Hospital Sharjah
Sharjah city
Zahi BADRAN, zbadran@sharjah.ac.ae
About this study
Official title: Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis: A Split Mouth Randomized Controlled Trial
General Objective :
To evaluate the outcome of non surgical periodontal therapy with local drug delivery adjunct to scaling and root planning
Specific Objective :
To determine the effect of intra-pocket application of hyaluronic acid /chlorohexidine gel in non surgical periodontal treatment on clinical periodontal parameters and microbiological level .
- Conditions
- Periodontitis, Hyaluronic Acid, Chlorhexidine
- Being tested
- Non surgical periodontal therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non surgical periodontal therapyProcedure or surgery
Subgingival ultrasonic debridement + manual root planning
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | NS therapy + Chlorhexidine/Hyaluronic acid subgingival gel application Receives: Procedure: Non surgical periodontal therapy |
| Control | Placebo comparator | NS therapy + Placebo gel subgingival application Receives: Procedure: Non surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pocket depth
Measured: 2 months
Bleeding on Probing
Measured: 2 months
Clinical attachment level
Measured: 2 months
Secondary outcomes (1)
Plaque index
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Oct 2022
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split mouth RCT
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahi BADRAN, University of Sharjah
- Investigators
- Zahi BADRAN, Phd, Study director, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682833
- Sponsor's protocol ID
- REC-22-02-26-S
- Status last verified
- Jan 2023
- First submitted
- 28 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis: A Split Mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05682833
- Acronym / sponsor ID
- REC-22-02-26-S
- Conditions
- Periodontitis, Hyaluronic Acid, Chlorhexidine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 12 Jan 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.
General Objective :
To evaluate the outcome of non surgical periodontal therapy with local drug delivery adjunct to scaling and root planning
Specific Objective :
To determine the effect of intra-pocket application of hyaluronic acid /chlorohexidine gel in non surgical periodontal treatment on clinical periodontal parameters and microbiological level .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Split mouth RCT
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Procedure: Non surgical periodontal therapyNS therapy + Chlorhexidine/Hyaluronic acid subgingival gel application |
| Control | Placebo comparator | Procedure: Non surgical periodontal therapyNS therapy + Placebo gel subgingival application |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age : 20-60 years old
- At least 20 remaining teeth
- Periodontitis stage III and IV ,Grade A, B and C
Key exclusion criteria (7 listed)
- Patients taking specific medications: antibiotic , anticoagulants or anti-inflammatory
- Previous periodontal therapy in the past 3-6 months.
- Immunocompromised patients
- Systemically diseased patients: Diabetes ,osteoporosis etc
- History of allergies or hypersensitivity reactions to chlorohexidine or Hyaluronic acid
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 periodontal therapySubgingival ultrasonic debridement + manual root planning | Procedure or surgery | Control, Test |
Primary outcome
pocket depth
Time frame: 2 months
Bleeding on Probing
Time frame: 2 months
Clinical attachment level
Time frame: 2 months
1 secondary outcome
Plaque index
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Zahi BADRAN, Phd study director
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non surgical periodontal therapy in people with Periodontitis and Hyaluronic Acid, run by University of Sharjah at 1 site in United Arab Emirates.
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 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 12 Jan 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 United Arab Emirates. 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.
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 Prof. Zahi Badran Prof. (+97165057353, zbadran@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pocket depth (time frame: 2 months). 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?
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 12 Jan 2023.