Periodontal DiseasePhase 2PRNCT01113528
Omega-3 and Aspirin in Periodontal Regeneration
A Phase 2 study testing Regenerative therapy (omega 3 PUFA plus low dose aspirin) and Sugar pill in people with Periodontal Disease, run by October 6 University at 1 site in Egypt.
Trial summary
To evaluate the efficacy of systemic administration of omega 3 PUFA plus low dose aspirin as an adjunctive therapy to regenerative modality of grade II furcation defects in periodontitis patients. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Regenerative therapy (omega 3 PUFA plus low dose aspirin) and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2009to May 2010
- Phase
- Phase 2
- 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- suffering moderate to sever chronic periodontitis and displaying at least a single grade II furcation defect according to Glickman's classification 1953, determined by both clinical and radiographic examinations;
- free from systemic diseases known to influence the periodontal condition and not receiving any medication known to affect the periodontal status;
- have not receive any periodontal therapy for a minimum of 6 months prior to the study.
Who cannot join
- Known hypersensitivity or allergy to one of the used medications
- Pregnancy or lactation
- Heavy smoking (more than 10cigarretes/day)
- History of alcohol abuse
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Host Response Modulation Therapy (Omega 3 Plus Low-dose Aspirin) as an Adjunctive Treatment of Chronic Periodontitis (Clinical and Biochemical Study)
To evaluate the efficacy of systemic administration of omega 3 PUFA plus low dose aspirin as an adjunctive therapy to regenerative modality of grade II furcation defects in periodontitis patients.
Read the detailed description
In this study, we tested the hypothesis that the administration of omega 3 PUFA plus low dose aspirin would augment the results following regenerative therapy of furcation defects in chronic periodontitis patients.
- Conditions
- Periodontal Disease
- Being tested
- Regenerative therapy (omega 3 PUFA plus low dose aspirin), Sugar pill
- Keywords
- Bone allograft, IL-1, IL-10, periodontal regeneration, omega-3, aspirin
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative therapy (omega 3 PUFA plus low dose aspirin)Other
Also called Omega, Fish oil, ASA, low dose aspirin
Comparison between regenerative bone graft alone and bone graft + Omega-3 and low dose aspirin
Sugar pillDrug
Also called Gelatinous capsules
3 times daily
| Study group | Role | What they receive |
|---|---|---|
| Regenerative therapy | Experimental | Not described Receives: Other: Regenerative therapy (omega 3 PUFA plus low dose aspirin) |
| Sugar pill | Placebo comparator | Not described Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine levels
Interleukin-1 beta Interleukin-10
Measured: six months
Secondary outcomes (2)
Gingival inflammation
plaque index Gingival index Gingival bleeding index
Measured: six months
Healing after regenerative therapy
Probing pocket depth Clinical attachment level
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Investigators
- Amr M. Elkhouli, ph.D, Principal investigator, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113528
- Sponsor's protocol ID
- HHDA-1962
- Other IDs
- October 6 U 196222
- Acronym
- PR
- Status last verified
- May 2010
- First submitted
- 23 Apr 2010
- Last updated
- 14 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Host Response Modulation Therapy (Omega 3 Plus Low-dose Aspirin) as an Adjunctive Treatment of Chronic Periodontitis (Clinical and Biochemical Study)
- ClinicalTrials.gov ID
- NCT01113528
- Acronym / sponsor ID
- PR / HHDA-1962
- Conditions
- Periodontal Disease
- Keywords
- Bone allograft, IL-1, IL-10, periodontal regeneration, omega-3, aspirin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Nov 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Apr 2010 (estimated)
- 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.
To evaluate the efficacy of systemic administration of omega 3 PUFA plus low dose aspirin as an adjunctive therapy to regenerative modality of grade II furcation defects in periodontitis patients.
Detailed description
In this study, we tested the hypothesis that the administration of omega 3 PUFA plus low dose aspirin would augment the results following regenerative therapy of furcation defects in chronic periodontitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regenerative therapy | Experimental | Other: Regenerative therapy (omega 3 PUFA plus low dose aspirin) |
| Sugar pill | Placebo comparator | Drug: Sugar pill |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- suffering moderate to sever chronic periodontitis and displaying at least a single grade II furcation defect according to Glickman's classification 1953, determined by both clinical and radiographic examinations;
- free from systemic diseases known to influence the periodontal condition and not receiving any medication known to affect the periodontal status;
- have not receive any periodontal therapy for a minimum of 6 months prior to the study.
Key exclusion criteria (5 listed)
- Known hypersensitivity or allergy to one of the used medications
- Pregnancy or lactation
- Heavy smoking (more than 10cigarretes/day)
- History of alcohol abuse
- Participation in other clinical trials
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 |
|---|---|---|
| Regenerative therapy (omega 3 PUFA plus low dose aspirin)Also: Omega, Fish oil, ASA, low dose aspirinComparison between regenerative bone graft alone and bone graft + Omega-3 and low dose aspirin | Other | Regenerative therapy |
| Sugar pillAlso: Gelatinous capsules3 times daily | Drug | Sugar pill |
Primary outcome
Cytokine levels
Time frame: six months
Interleukin-1 beta Interleukin-10
2 secondary outcomes
Gingival inflammation
Time frame: six months
Healing after regenerative therapy
Time frame: six 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 14 May 2010.
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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.
Amr M. Elkhouli, ph.D principal investigator
October 6 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Regenerative therapy (omega 3 PUFA plus low dose aspirin) and Sugar pill in people with Periodontal Disease, run by October 6 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 3 inclusion and 5 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 14 May 2010. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cytokine levels (time frame: six months). 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 14 May 2010.