Chronic Periodontitis, GeneralizedNCT05823389
Flapless Emdogain in the Treatment of Periodontal Residual Pockets
A study testing Re-instrumentation with flapless Emdogain application in people with Chronic Periodontitis, Generalized, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
Trial summary
48 adult patients participated in a single-centre randomized clinical trial with split- mouth design. They had presented at re-evaluation after initial non-surgical periodontal therapy (steps 1 and 2 of periodontal therapy) for generalized periodontitis with at least 2 teeth with residual probing pocket depths (PPD)… Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Generalized
- What is being tested?
- Re-instrumentation with flapless Emdogain application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 2 Sep 2019to 15 Dec 2022
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least two residual pockets with probing pocket depth (PPD) ≥5 and ≤8 mm,
- bleeding on probing (BOP),
- mobility ≤degree 1 and
- no furcation involvement.
Who cannot join
- full mouth plaque score >20%,
- uncontrolled systemic disease,
- history of malignant disease in the oral cavity or previous radiotherapy in the head or neck area,
- pregnant or lactating females,
- drug and alcohol abuse,
- smoking >10 cigarettes per day and
- inadequate restorative therapy or malocclusion.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Arab American University
Ramallah, 240
About this study
Official title: The Use of Flapless Enamel Matrix Derivative in Treating Periodontal Residual Pockets: A Single-centre Randomized Clinical Trial
48 adult patients participated in a single-centre randomized clinical trial with split- mouth design. They had presented at re-evaluation after initial non-surgical periodontal therapy (steps 1 and 2 of periodontal therapy) for generalized periodontitis with at least 2 teeth with residual probing pocket depths (PPD) ≥5 and ≤8 mm, with bleeding on probing (BOP). Two teeth with similar PPD were randomized to receive re-instrumentation either with (test) or without (control) adjunctive flapless administration of EMD. Differences in the changes of PPD and BOP from baseline to 6 and 12 months will be analysed, and the frequencies of pocket closure (PPD ≤4 mm and no BOP) will be compared
- Conditions
- Chronic Periodontitis, Generalized
- Being tested
- Re-instrumentation with flapless Emdogain application, Re-instrumentation with placebo application
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-instrumentation with flapless Emdogain applicationProcedure or surgery
Teeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive flapless administration of EMD
Re-instrumentation with placebo applicationProcedure or surgery
Teeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive placebo application
| Study group | Role | What they receive |
|---|---|---|
| Flapless Emdogain (FEMD) group | Experimental | Re-instrumentation with flapless emdogain application Receives: Procedure: Re-instrumentation with flapless Emdogain application |
| Placebo group | Active comparator | Re-instrumentation without flapless emdogain application Receives: Procedure: Re-instrumentation with placebo application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in changes of probing pocket depths (PPD) from baseline to 6 and 12 months
probing pocket depth (PPD)
Measured: 12 months
Differences in changes of bleeding on probing (BOP) from baseline to 6 and 12 months
bleeding on probing (BOP)
Measured: 12 months
Secondary outcomes (1)
frequencies of pocket closure
PPD ≤4 mm
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start2 Sep 2019
- Primary completion1 Oct 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Periodontitis, GeneralizedStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823389
- Sponsor's protocol ID
- EMD
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 21 Apr 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 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Flapless Enamel Matrix Derivative in Treating Periodontal Residual Pockets: A Single-centre Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05823389
- Acronym / sponsor ID
- EMD
- Conditions
- Chronic Periodontitis, Generalized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Arab American University (Palestine)University, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 21 Apr 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.
48 adult patients participated in a single-centre randomized clinical trial with split- mouth design. They had presented at re-evaluation after initial non-surgical periodontal therapy (steps 1 and 2 of periodontal therapy) for generalized periodontitis with at least 2 teeth with residual probing pocket depths (PPD) ≥5 and ≤8 mm, with bleeding on probing (BOP). Two teeth with similar PPD were randomized to receive re-instrumentation either with (test) or without (control) adjunctive flapless administration of EMD. Differences in the changes of PPD and BOP from baseline to 6 and 12 months will be analysed, and the frequencies of pocket closure (PPD ≤4 mm and no BOP) will be compared
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flapless Emdogain (FEMD) group | Experimental | Procedure: Re-instrumentation with flapless Emdogain applicationRe-instrumentation with flapless emdogain application |
| Placebo group | Active comparator | Procedure: Re-instrumentation with placebo applicationRe-instrumentation without flapless emdogain application |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least two residual pockets with probing pocket depth (PPD) ≥5 and ≤8 mm,
- bleeding on probing (BOP),
- mobility ≤degree 1 and
- no furcation involvement.
Key exclusion criteria (7 listed)
- full mouth plaque score >20%,
- uncontrolled systemic disease,
- history of malignant disease in the oral cavity or previous radiotherapy in the head or neck area,
- pregnant or lactating females,
- drug and alcohol abuse,
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 |
|---|---|---|
| Re-instrumentation with flapless Emdogain applicationTeeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive flapless administration of EMD | Procedure or surgery | Flapless Emdogain (FEMD) group |
| Re-instrumentation with placebo applicationTeeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive placebo application | Procedure or surgery | Placebo group |
Primary outcome
Differences in changes of probing pocket depths (PPD) from baseline to 6 and 12 months
Time frame: 12 months
probing pocket depth (PPD)
Differences in changes of bleeding on probing (BOP) from baseline to 6 and 12 months
Time frame: 12 months
bleeding on probing (BOP)
1 secondary outcome
frequencies of pocket closure
Time frame: 12 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 21 Apr 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.
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 study testing Re-instrumentation with flapless Emdogain application in people with Chronic Periodontitis, Generalized, 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 4 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: finished, as of the sponsor's last update on 21 Apr 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?
Differences in changes of probing pocket depths (PPD) from baseline to 6 and 12 months (time frame: 12 months). The study lists 2 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 21 Apr 2023.