Chronic PeriodontitisNCT02679209
Evaluation of Amnion Chorion Membrane and Demineralized Bone Matrix Putty Allograft in Periodontal Intrabony Defects
A study testing Demineralized bone matrix in putty form and Amnion chorion membrane in people with Chronic Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
A clinical and radiographic evaluation of 2 regenerative techniques, bioresorbable membrane and bone allograft for management of periodontal intrabony defects. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Demineralized bone matrix in putty form and Amnion chorion membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2015to 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 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Severe chronic periodontitis patients.
- having at least one site with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss as detected in periapical radiographs.
Who cannot join
- Pregnant women
- Having any given systemic disease
- Taking any type of medication and/or antibiotic therapy during the 3 months before the study
- Received periodontal treatment within the past 12 months Current or former smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Amnion Chorion Membrane and Demineralized Bone Matrix Putty Allograft for Management of Periodontal Intrabony Defects: a Randomized Clinical Trial.
A clinical and radiographic evaluation of 2 regenerative techniques, bioresorbable membrane and bone allograft for management of periodontal intrabony defects.
Read the detailed description
Twenty-two patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed had two- or three-walled intrabony defects. Patients were randomly assigned into two groups; bioresorbable membrane or bone allograft. Clinical parameters were recorded at baseline and at 3 and 6 months postoperatively. Radiographic parameters were recorded at baseline and at 6 months postoperatively.
- Conditions
- Chronic Periodontitis
- Being tested
- Demineralized bone matrix in putty form, Amnion chorion membrane
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demineralized bone matrix in putty formBiological
Also called DBM
it is a type of bone graft from human cadavers.
Amnion chorion membraneBiological
Also called bioresorbable membrane
A bioresorbable allograft membrane for guided tissue regeneration from amnion and chorion parts of the placenta from pregnant females for guided tissue regeneration.
| Study group | Role | What they receive |
|---|---|---|
| Bone allograft | Experimental | commercially available demineralized bone matrix putty allograft will be used to fill in the defect after opening a periodontal flap Receives: Biological: Demineralized bone matrix in putty form |
| Amnion chorion membrane | Experimental | Amnion chorion commercially available allograft bioresorbable membrane as a guided tissue regeneration technique will be used to in the defect after opening a periodontal flap Receives: Biological: Amnion chorion membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level
Change from baseline in clinical attachment level in mm in chronic periodontitis patients
Measured: change from Baseline at 6 months
Secondary outcomes (2)
pocket depth
Estimation of pocket depth in mm in chronic periodontitis patients at baseline and 6 months
Measured: Baseline and 6 months
bone defect area
Estimation of bone fill defect area in mm square in chronic periodontitis patients at baseline and 6 month
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ayman Ghallab, Cairo University
- Investigators
- Riham Hamdy, pHD, Study chair, Associate Professor of Oral and Maxillofacial RadiologyAmr Temraz, BDs, Principal investigator, Master student at Oral medicine and Periodontology departmentOmnia Abouldahab, phD, Study director, Professor of Oral Medicine & Periodontology, Cairo Unv.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679209
- Sponsor's protocol ID
- Aminonchorion_DBM
- Status last verified
- Apr 2018
- First submitted
- 7 Feb 2016
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Kothiwale SV, Anuroopa P, Gajiwala AL. A clinical and radiological evaluation of DFDBA with amniotic membrane versus bovine derived xenograft with amniotic membrane in human periodontal grade II furcation defects. Cell Tissue Bank. 2009 Nov;10(4):317-26. doi: 10.1007/s10561-009-9126-3. Epub 2009 Mar 10.
PubMed 19277899
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Amnion Chorion Membrane and Demineralized Bone Matrix Putty Allograft for Management of Periodontal Intrabony Defects: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02679209
- Acronym / sponsor ID
- Aminonchorion_DBM
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 10 Feb 2016 (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.
A clinical and radiographic evaluation of 2 regenerative techniques, bioresorbable membrane and bone allograft for management of periodontal intrabony defects.
Detailed description
Twenty-two patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed had two- or three-walled intrabony defects. Patients were randomly assigned into two groups; bioresorbable membrane or bone allograft. Clinical parameters were recorded at baseline and at 3 and 6 months postoperatively. Radiographic parameters were recorded at baseline and at 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone allograft | Experimental | Biological: Demineralized bone matrix in putty formcommercially available demineralized bone matrix putty allograft will be used to fill in the defect after opening a periodontal flap |
| Amnion chorion membrane | Experimental | Biological: Amnion chorion membraneAmnion chorion commercially available allograft bioresorbable membrane as a guided tissue regeneration technique will be used to in the defect after opening a periodontal flap |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Severe chronic periodontitis patients.
- having at least one site with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss as detected in periapical radiographs.
Key exclusion criteria (4 listed)
- Pregnant women
- Having any given systemic disease
- Taking any type of medication and/or antibiotic therapy during the 3 months before the study
- Received periodontal treatment within the past 12 months Current or former 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 |
|---|---|---|
| Demineralized bone matrix in putty formAlso: DBMit is a type of bone graft from human cadavers. | Biological | Bone allograft |
| Amnion chorion membraneAlso: bioresorbable membraneA bioresorbable allograft membrane for guided tissue regeneration from amnion and chorion parts of the placenta from pregnant females for guided tissue regeneration. | Biological | Amnion chorion membrane |
Primary outcome
Clinical attachment level
Time frame: change from Baseline at 6 months
Change from baseline in clinical attachment level in mm in chronic periodontitis patients
2 secondary outcomes
pocket depth
Time frame: Baseline and 6 months
bone defect area
Time frame: Baseline and 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 24 Apr 2018.
- Background: PubMed 19277899Kothiwale SV, Anuroopa P, Gajiwala AL. A clinical and radiological evaluation of DFDBA with amniotic membrane versus bovine derived xenograft with amniotic membrane in human periodontal grade II furcation defects. Cell Tissue Bank. 2009 Nov;10(4):317-26. doi: 10.1007/s10561-009-9126-3. Epub 2009 Mar 10.
- 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.
Riham Hamdy, pHD study chair
Associate Professor of Oral and Maxillofacial Radiology
Amr Temraz, BDs principal investigator
Master student at Oral medicine and Periodontology department
Omnia Abouldahab, phD study director
Professor of Oral Medicine & Periodontology, Cairo Unv.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Demineralized bone matrix in putty form and Amnion chorion membrane 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 2 inclusion and 4 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 24 Apr 2018. 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?
Clinical attachment level (time frame: change from Baseline at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02679209, which also lists 1 linked publication.
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 24 Apr 2018.