Periodontal DiseasesNCT05756946
Guided Tissue Regeneration With a Periodontal Dressing
A study testing periodontal dressing (coe-pak) and Guided Tissue Regeneration in people with Periodontal Diseases, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
Trial summary
This randomized, controlled split-mouth study will include 24-40 patients. After GTR, a test and a control side will be selected by means of a computer-generated randomization list. Test sides will receive a periodontal dressing (Coepak") for 14 days and the control sides will receive no periodontal dressing. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- periodontal dressing (coe-pak) and Guided Tissue Regeneration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Mar 2023to 15 Apr 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years.
- A minimum of 18 teeth, wisdom teeth excluded.
- Previously untreated moderate chronic periodontitis (Armitage 1999) with radiographic evidence of generalized alveolar bone loss >30%.
- Presence of at least one pocket with probing pocket depth (PPD) ≥6 mm per quadrant, which was BOP.
- Presence of at least three teeth per quadrant.
Who cannot join
- Periodontal treatment in the last 3 years.
- Antibiotic intake 6 months before • the screening visit.
- Pregnancy. Systemic diseases with an impact on periodontal healing (e.g. Dia- betes).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guided Tissue Regeneration Combined With Periodontal Dressing: A Randomized Controlled Clinical Trial for the Treatment of Periodontal Defects
This randomized, controlled split-mouth study will include 24-40 patients. After GTR, a test and a control side will be selected by means of a computer-generated randomization list. Test sides will receive a periodontal dressing (Coepak") for 14 days and the control sides will receive no periodontal dressing. After 14 days the periodontal dressing will be removed and the pain experience will be recorded. After 6-9 months, the clinical periodontal parameters will be recorded.
- Conditions
- Periodontal Diseases
- Being tested
- periodontal dressing (coe-pak), Guided Tissue Regeneration
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal dressing (coe-pak)Procedure or surgery
Guided tissue regeneration and periodontal dressing
Guided Tissue RegenerationProcedure or surgery
Also called GTR
Regeneration of lost periodontal tissues
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Test group will receive GTR + periodontal dressing (Coe-pak) Receives: Procedure: periodontal dressing (coe-pak); Procedure: Guided Tissue Regeneration |
| Control group | Active comparator | Control group will receive GTR only Receives: Procedure: Guided Tissue Regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain experience
pain experience will be measured 14 days after GTR procedure; when the dressing is removed. Participants have to fill a VAS score out about pain intensity on a scale from 0 to 10 (0 = no pain, 5 = moderate pain and 10 = worst imaginable pain) and the amount of pain medication taken will be recorded
Measured: 14 days
Secondary outcomes (2)
Probing pocket depth
changes in periodontal probing pocket depth in mm
Measured: 6 months
Attachment level
changes in clinical attachment level in mm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Mar 2023
- Primary completion10 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arab American University (Palestine)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abu-Ta'a, Arab American University (Palestine)
- Investigators
- Mahmoud Abu-Ta'a, Principal investigator, Department of Dental sciences, Faculty of Graduate Studies, Arab American University (AAUP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756946
- Sponsor's protocol ID
- GTR
- Status last verified
- Jul 2023
- First submitted
- 15 Feb 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Tissue Regeneration Combined With Periodontal Dressing: A Randomized Controlled Clinical Trial for the Treatment of Periodontal Defects
- ClinicalTrials.gov ID
- NCT05756946
- Acronym / sponsor ID
- GTR
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Arab American University (Palestine)University, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 7 Mar 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.
This randomized, controlled split-mouth study will include 24-40 patients. After GTR, a test and a control side will be selected by means of a computer-generated randomization list. Test sides will receive a periodontal dressing (Coepak") for 14 days and the control sides will receive no periodontal dressing. After 14 days the periodontal dressing will be removed and the pain experience will be recorded. After 6-9 months, the clinical periodontal parameters will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: periodontal dressing (coe-pak), Procedure: Guided Tissue RegenerationTest group will receive GTR + periodontal dressing (Coe-pak) |
| Control group | Active comparator | Procedure: Guided Tissue RegenerationControl group will receive GTR only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 75 years.
Key exclusion criteria (3 listed)
- Periodontal treatment in the last 3 years.
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 dressing (coe-pak)Guided tissue regeneration and periodontal dressing | Procedure or surgery | Test group |
| Guided Tissue RegenerationAlso: GTRRegeneration of lost periodontal tissues | Procedure or surgery | Control group, Test group |
Primary outcome
Pain experience
Time frame: 14 days
pain experience will be measured 14 days after GTR procedure; when the dressing is removed. Participants have to fill a VAS score out about pain intensity on a scale from 0 to 10 (0 = no pain, 5 = moderate pain and 10 = worst imaginable pain) and the amount of pain medication taken will be recorded
2 secondary outcomes
Probing pocket depth
Time frame: 6 months
Attachment level
Time frame: 6 months
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 20 Jul 2023.
- 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.
Mahmoud Abu-Ta'a principal investigator
Department of Dental sciences, Faculty of Graduate Studies, Arab American University (AAUP)
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 dressing (coe-pak) and Guided Tissue Regeneration in people with Periodontal Diseases, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
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 3 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 20 Jul 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 Palestinian Territories. 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?
Pain experience (time frame: 14 days). 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 20 Jul 2023.