- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01860495
Gingival Crevicular Fluid Bone Morphogenetic Protein - 2 Release Profile Following the Use of Perforated Membrane (MPM)
May 21, 2013 updated by: Ahmed Y Gamal, Al-Azhar University
Gingival Crevicular Fluid Bone Morphogenetic Protein - 2 Release Profile Following the Use of Modified Perforated Membrane Barriers in Localized Intrabony Defects (An in Vivo Study)
One of the most important elements suggested to be provided through membrane perforations to augment regeneration are cell released growth factors from the overlying periosteal and gingival cells.
A direct correlation could exist between the number of such cells and their available released growth factors.
To test this assumption, this study was designed to evaluate levels of bone morphogenetic protein-2 in gingival crevicular fluid (GCF) during the early stages of healing for sites treated by MPM compared to that of the occlusive barrier membranes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The subjects were recruited consecutively from the list of patients seeking care for periodontal problems at the Department of Periodontology of the Faculty of Dental Medicine, Al Azhar University, Cairo, Egypt, between March 2012 to December 2012.
The criteria implemented for patient inclusion were: 1) no systemic diseases which could influence the outcome of the therapy; 2) good compliance with the plaque control instructions following initial therapy; 3) teeth involved were all vital with score 0 mobility ; 4) each subject contributed matched pairs of two or three walled intrabony interproximal defects in premolar or molar teeth 5) the selected 2- or 3-wall intrabony defect depth ranged from 3-5 mm as detected in diagnostic periapical radiographs; 6) selected pocket depth (PD) ≥ 6 mm and clinical attachment level (CAL) ≥ 5 mm at the site of endosseous defect four weeks following initial cause-related therapy 7) endosseous radiographic defect angle ≤55 and ≥15 8) availability for the follow-up and maintenance program; 9) absence of periodontal treatment for the previous year; 10) absence of systemic medication or antibiotic treatment for the previous 6 months; 11) absence of a smoking habit and 12) absence of occlusal interferences.
Pregnant females were excluded from participating in the study.
Patients were also excluded from the study if they presented with opened interproximal contact, or inadequate compliance with the oral hygiene maintenance schedule.
The experimental protocol was approved by the Ethical Committee of El Azhar University (OMD - 45 - 2012, clinical trial registration number: Al Azhar University 22-31).
Research procedures were explained to all patients and they agreed to participate in the study and signed the appropriate informed consent form of Al Azhar University.
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo Governorate, Egypt, 1123
- al azhar universty
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
31 years to 51 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Fifteen non-smoking patients (8 males and 7 females) who were 31 to 51 years of age at the time of baseline examination (mean age 33.8 ± 6.1) with severe chronic periodontitis (Armitage 1999) participated in this prospective, randomized and blinded clinical trial.
The subjects were recruited consecutively from the list of patients seeking care for periodontal problems at the Department of Periodontology of the Faculty of Dental Medicine, Al Azhar University, Cairo, Egypt, between March 2012 to December 2012.
The experimental protocol was approved by the Ethical Committee of El Azhar University (OMD - 45 - 2012).
Research procedures were explained to all patients and they agreed to participate in the study and signed the appropriate informed consent form of Al Azhar University.
Description
Inclusion Criteria:
- no systemic diseases which could influence the outcome of the therapy;
- good compliance with the plaque control instructions following initial therapy;
- teeth involved were all vital with score 0 mobility ;
- each subject contributed matched pairs of two or three walled intrabony interproximal defects in premolar or molar teeth
- the selected 2- or 3-wall intrabony defect depth ranged from 3-5 mm as detected in diagnostic periapical radiographs;
- selected pocket depth (PD) ≥ 6 mm and clinical attachment level (CAL) ≥ 5 mm at the site of endosseous defect four weeks following initial cause-related therapy
- endosseous radiographic defect angle ≤55 and ≥15
- availability for the follow-up and maintenance program;
- absence of periodontal treatment for the previous year;
- absence of systemic medication or antibiotic treatment for the previous 6 months;
- absence of a smoking habit and
- absence of occlusal interferences.
Exclusion Criteria:
- Pregnant females were excluded from participating in the study.
- Patients were also excluded from the study if they presented with opened interproximal contact, or inadequate compliance with the oral hygiene maintenance schedule.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
perforated membrane group
perforated membrane group (G1- 15 sites)
|
perforated membrane that could give a chance for posetive contributionn of periosteal and gingival mesenchymal stem cells in periodontal regeneration
Other Names:
|
occlusive membrane group
occlusive collagen membrane that are tradetionally used in guided tissue regeneration , control occlusive group (G2-15 sites)
|
tradetional occlusive collagen membrane
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gingival cervicular fluid BMP-2 level
Time Frame: 30 days
|
Using capillary tube (5 µl), gingival cervicular fluid (GCF) samples were collected (Sueda et al, 1969) by a single examiner (MA) who was masked to the attribution of the sites to MPM or OM.
Following the isolation and drying of the selected site with cotton rolls, a fisher brand disposable micropipettes €, placed intrasulculary at the mesiofacial line angle of the selected site to a maximum depth of 2 mm below the gingival margin.
Micropipettes were left in place until 5ul of fluid was collected.
Gingival cervicular fluid (GCF) samples were collected one day, 3, 7, 14, 21, and 30 days after therapy and diluted in saline solution (50 µl) for bone morphogenetic protein-2 level evaluation.
Samples were labeled, carried in a dark container and kept at -80 C until used.
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intrabony components (defect bony filling)
Time Frame: 9 months
|
Clinical and radiographic measurements (pocket depth, attachement level, gingival index , plaque index, intrabony level) were reassessed at 3, 6, and 9 months after surgery.
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9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahmed Y Gamal, PhD, Al Azhar universty, faculty of dentistry, cairo, egypt
- Study Director: Mohamed M Aziz, BCH, al azhar universty, cairo, egypt
- Study Director: Mohamed M Helmy, MSD, al azhar universty
- Study Chair: Vencint J Iacono, PhD, Stony Brook Uiversty
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
May 19, 2013
First Submitted That Met QC Criteria
May 21, 2013
First Posted (Estimate)
May 22, 2013
Study Record Updates
Last Update Posted (Estimate)
May 22, 2013
Last Update Submitted That Met QC Criteria
May 21, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ahmedgamal
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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