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

NCT ID: NCT01860495

Last Updated: 2013-05-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-12-31

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.

Conditions

Periodontal Pocket

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

perforated membrane group

perforated membrane group (G1- 15 sites)

perforated membrane

Intervention Type: PROCEDURE

perforated membrane that could give a chance for posetive contributionn of periosteal and gingival mesenchymal stem cells in periodontal regeneration

occlusive membrane group

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

G2

Intervention Type: PROCEDURE

tradetional occlusive collagen membrane

Interventions

perforated membrane

perforated membrane that could give a chance for posetive contributionn of periosteal and gingival mesenchymal stem cells in periodontal regeneration

Intervention Type: PROCEDURE

G2

tradetional occlusive collagen membrane

Intervention Type: PROCEDURE

Other Intervention Names

collagen membranes; guided tissue membranes

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.

• Minimum Eligible Age: 31 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Y Gamal

professor of periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Y Gamal, PhD

Role: PRINCIPAL_INVESTIGATOR

Al Azhar universty, faculty of dentistry, cairo, egypt

Mohamed M Aziz, BCH

Role: STUDY_DIRECTOR

al azhar universty, cairo, egypt

Mohamed M Helmy, MSD

Role: STUDY_DIRECTOR

al azhar universty

Vencint J Iacono, PhD

Role: STUDY_CHAIR

Stony Brook Uiversty

Locations

Al azhar universty

Cairo Governorate, Egypt, Egypt

Countries

Egypt

References

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.

Reference Type: RESULT

PMID: 23003916 (View on PubMed)

Other Identifiers

ahmedgamal

Identifier Type: -

Identifier Source: org_study_id