Gingival Crevicular Fluid Bone Morphogenetic Protein - 2 Release Profile Following the Use of Perforated Membrane

Completed

• Conditions: Periodontal Pocket
• Interventions: Procedure: perforated membrane; Procedure: G2

• Registration Number: NCT01860495
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-05
• Study Completion: 2012-12
• Status Verified: 2013-05
• Study First Submitted: 2013-05-19
• Study First Submitted QC: 2013-05-21
• Last Update Submitted: 2013-05-21
• Study First Posted: 2013-05-22
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
perforated membrane group	perforated membrane	perforated membrane group (G1- 15 sites)
occlusive membrane group	G2	occlusive collagen membrane that are tradetionally used in guided tissue regeneration , control occlusive group (G2-15 sites)

Primary Outcome Measures

Name	Time	Method
gingival cervicular fluid BMP-2 level	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.

Secondary Outcome Measures

Name	Time	Method
intrabony components (defect bony filling)	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.

Trial Locations

Locations (1)

Al azhar universty; 🇪🇬 Cairo Governorate, Egypt