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

NCT01860495 | Completed DMC

• 1 other identifier: ahmedgamal
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Pocket

Keywords

growth factors; periodontal pockets

Outcome Measures

Primary Outcomes (1)

• gingival cervicular fluid BMP-2 level

  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.

  30 days

Secondary Outcomes (1)

• intrabony components (defect bony filling)

  9 months

Study Arms (2)

perforated membrane group

perforated membrane group (G1- 15 sites)

Procedure: perforated membrane

occlusive membrane group

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

Procedure: G2

Interventions

perforated membrane PROCEDURE

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

Also known as: collagen membranes

perforated membrane group

G2 PROCEDURE

tradetional occlusive collagen membrane

Also known as: guided tissue membranes

occlusive membrane group

Eligibility Criteria

• Age: 31 Years - 51 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al azhar universty

Cairo Governorate, Egypt, 1123, Egypt

Location

Related Publications (1)

• 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.

  PMID: 23003916 RESULT

MeSH Terms

Conditions

Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ahmed Y Gamal, PhD

  Al Azhar universty, faculty of dentistry, cairo, egypt

  PRINCIPAL INVESTIGATOR

• Mohamed M Aziz, BCH

  al azhar universty, cairo, egypt

  STUDY DIRECTOR

• Mohamed M Helmy, MSD

  al azhar universty

  STUDY DIRECTOR

• Vencint J Iacono, PhD

  Stony Brook Uiversty

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of periodontology

Study Record Dates

• First Submitted: May 19, 2013
• First Posted: May 22, 2013
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 22, 2013

Record last verified: 2013-05

Locations

EG (1)