Clinical trial NCT01860495: Gingival Crevicular Fluid Bone Morphogenetic Protein - 2 Release Profile Following the Use of Perforated Membrane
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Pocket
Keywords: growth factors
periodontal pockets
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 15
Sex: ALL
Minimum age (years): 31
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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.

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.

Primary outcomes:
measure: gingival cervicular fluid BMP-2 level
timeFrame: 30 days
Secondary outcomes:
measure: intrabony components (defect bony filling)
timeFrame: 9 months
Other outcomes:
Locations:
city: Cairo Governorate
country: Egypt
facility: Al azhar universty
Study officials:
affiliation: Al Azhar universty, faculty of dentistry, cairo, egypt
name: Ahmed Y Gamal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: al azhar universty, cairo, egypt
name: Mohamed M Aziz, BCH
role: STUDY_DIRECTOR
affiliation: al azhar universty
name: Mohamed M Helmy, MSD
role: STUDY_DIRECTOR
affiliation: Stony Brook Uiversty
name: Vencint J Iacono, PhD
role: STUDY_CHAIR
References:
citation: Gamal AY, Iacono VJ. Enhancing guided tissue regeneration of periodontal defects by using a novel perforated barrier membrane. J Periodontol. 2013 Jul;84(7):905-13. doi: 10.1902/jop.2012.120301. Epub 2012 Sep 24.