Chronic PeriodontitisNCT03807596
Hyaluronic Acid With Scaling & Root Planing In Chronic Periodontitis Patients With Diabetes Mellitus Type 2
A study testing Periodontal treatment with Hyaluronic acid associated with SRP and Scaling & root planning alone in people with Chronic Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
The present study aimed to assess the adjunctive use of Hyaluronic acid with scaling \& root planing (SRP) in patients with chronic periodontitis \& diabetes mellitus type 2. Read more about this study
- Who is it for?
- Ages 38 to 56 months
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Periodontal treatment with Hyaluronic acid associated with SRP and Scaling & root planning alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Mar 2017to 29 Jun 2017
- 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 38 to 56 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with chronic periodontitis and type 2 diabetes mellitus
- Minimum of 20 teeth
- Clinical attachment level (CAL) ≥ 3 mm
- Probing depth (PD) ≥ 4 mm.
Who cannot join
- Pregnant females
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjunctive Use Of Hyaluronic Acid With Scaling & Root Planing In Treatment of Chronic Periodontitis Patients With Diabetes Mellitus Type 2: A Randomized Controlled Trial
The present study aimed to assess the adjunctive use of Hyaluronic acid with scaling \& root planing (SRP) in patients with chronic periodontitis \& diabetes mellitus type 2.
Read the detailed description
Thirty subjects with chronic periodontitis \& diabetes mellitus type 2 were included in this randomized clinical trial. These subjects were randomly allocated into test \& control equal groups. The test group comprised fifteen patients who received SRP with subgingival application of Hyaluronic acid as an adjunct. The control group included fifteen patients who received SRP alone. Plaque index (PI), gingival index (GI), probing depth (PD) \& clinical attachment level (CAL) were measured \& documented at baseline, 6 weeks \& 12 weeks intervals.
- Conditions
- Chronic Periodontitis
- Being tested
- Periodontal treatment with Hyaluronic acid associated with SRP, Scaling & root planning alone
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal treatment with Hyaluronic acid associated with SRPProcedure or surgery
In addition to SRP, patients in the test group received adjunct subgingival application of hyaluronic acid in all selected periodontal pockets.
Scaling & root planning aloneProcedure or surgery
Patients received full-mouth supra- \& sub-gingival SRP with the use of ultrasonic device \& periodontal universal \& Gracey curettes under local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| SRP group | Active comparator | Chronic periodontitis patients with type 2 diabetes mellitus recieved Periodontal treatment in the form of scaling \& root planing (SRP) alone. Receives: Procedure: Scaling & root planning alone |
| Hyaluronic acid & SRP group | Experimental | Chronic periodontitis \& type 2 diabetes mellitus patients received Periodontal treatment in the form of scaling \& root planing (SRP) with the adjunctive use of hyaluronic acid. Receives: Procedure: Periodontal treatment with Hyaluronic acid associated with SRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gain in clinical attachment level
Gain in clinical attachment level will be measured in millimeter by William's graduated periodontal probe
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start16 Mar 2017
- Primary completion29 Jun 2017
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gihane Gharib Madkour, Cairo University
- Investigators
- Gihane G Madkour, Ass Prof, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807596
- Sponsor's protocol ID
- 15062011
- Status last verified
- Jan 2019
- First submitted
- 15 Jan 2019
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- 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 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Use Of Hyaluronic Acid With Scaling & Root Planing In Treatment of Chronic Periodontitis Patients With Diabetes Mellitus Type 2: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03807596
- Acronym / sponsor ID
- 15062011
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 17 Jan 2019 (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 aimed to assess the adjunctive use of Hyaluronic acid with scaling \& root planing (SRP) in patients with chronic periodontitis \& diabetes mellitus type 2.
Detailed description
Thirty subjects with chronic periodontitis \& diabetes mellitus type 2 were included in this randomized clinical trial. These subjects were randomly allocated into test \& control equal groups. The test group comprised fifteen patients who received SRP with subgingival application of Hyaluronic acid as an adjunct. The control group included fifteen patients who received SRP alone. Plaque index (PI), gingival index (GI), probing depth (PD) \& clinical attachment level (CAL) were measured \& documented at baseline, 6 weeks \& 12 weeks intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRP group | Active comparator | Procedure: Scaling & root planning aloneChronic periodontitis patients with type 2 diabetes mellitus recieved Periodontal treatment in the form of scaling \& root planing (SRP) alone. |
| Hyaluronic acid & SRP group | Experimental | Procedure: Periodontal treatment with Hyaluronic acid associated with SRPChronic periodontitis \& type 2 diabetes mellitus patients received Periodontal treatment in the form of scaling \& root planing (SRP) with the adjunctive use of hyaluronic acid. |
Who may qualify
- Ages
- 38 to 56 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients with chronic periodontitis and type 2 diabetes mellitus
- Minimum of 20 teeth
- Clinical attachment level (CAL) ≥ 3 mm
- Probing depth (PD) ≥ 4 mm.
Key exclusion criteria (2 listed)
- Pregnant females
- Smokers
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 |
|---|---|---|
| Periodontal treatment with Hyaluronic acid associated with SRPIn addition to SRP, patients in the test group received adjunct subgingival application of hyaluronic acid in all selected periodontal pockets. | Procedure or surgery | Hyaluronic acid & SRP group |
| Scaling & root planning alonePatients received full-mouth supra- \& sub-gingival SRP with the use of ultrasonic device \& periodontal universal \& Gracey curettes under local anesthesia. | Procedure or surgery | SRP group |
Primary outcome
Gain in clinical attachment level
Time frame: 12 weeks
Gain in clinical attachment level will be measured in millimeter by William's graduated periodontal probe
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 18 Jan 2019.
- Individual participant dataSharing planned: No
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Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
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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.
Gihane G Madkour, Ass Prof principal investigator
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 Periodontal treatment with Hyaluronic acid associated with SRP and Scaling & root planning alone in people with Chronic Periodontitis, 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 4 inclusion and 2 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 18 Jan 2019. 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?
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?
Gain in clinical attachment level (time frame: 12 weeks). 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 18 Jan 2019.