NCT05001919

Concentrated Growth Factors in Treatment of Intrabony Defects in Localized Aggressive Periodontitis

Concentrated Growth Factors Membrane in the Treatment of Intrabony Periodontal Defects in Localized Aggressive Periodontitis. A Randomized Controlled Split-Mouth Clinical Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A total of 20 intra-bony defects in 10 LAP patients were randomly assigned into two groups 10 defects each in a split-mouth design. Group I treated by surgery plus Bio-Oss bone graft + collagen membrane (Control group). Group II, treated by surgery plus Bio-Oss bone graft + CGF membrane (Test group). Gingival index (GI), bleeding on probing (BOP), probing pocket depth and clinical attachment level (CAL) were assessed at baseline, 3, 6, and 12 months. Cone beam radiograph evaluation was taken at baseline, and 12 months after surgery..

Detailed description

Full mouth scaling and root planing was done for all patients followed by Augmentin I gm and metronidazole 500 mg twice daily for 7 days. Additionally, Comprehensive oral hygiene instructions were given to the patients. Sites grouping Four weeks following phase I therapy, the twenty defect sites were randomly classified by sealed envelopes into two groups ten each by a masked supervisor as follows: Group I (10 sites) received surgery + Bio-oss bone graft (Geistlich Pharma AG, Wolhusen, Switzerland) + collagen membrane (control group). Group II (10 sites) received surgery + Bio-oss bone graft +concentrated growth factors membrane (tested group). After the administration of local anesthesia (Xylocaine 2% Adrenaline 1:80,000, ICPA, India), buccal and lingual sulcular incisions were made, and mucoperiosteal flaps were elevated. Thorough debridement of the defects was achieved with hand instruments. The surgical area was irrigated with copious amounts of sterile saline. Bio-oss granules were placed into the defects and the CGFs membrane was trimmed and adapted over the entire defect to cover 2-3 mm of the surrounding alveolar bone and to ensure the stability of the wound and the graft material. For control sites, Bio-oss grafts and a bioresorbable collagen membrane were trimmed and adjusted over the defect in such a way that the whole defect and 2-3 mm of the surrounding alveolar bone were completely covered. Then the flap was repositioned to achieve complete interproximal closure. The flap was then sutured with 4-0 absorbable sutures with single interrupted sutures. A periodontal pack was applied over the surgical area for 10 days.

Conditions

• Aggressive Periodontitis

Interventions

Type	Name	Description
PROCEDURE	GTR	intrabony defects treated by surgery and bone graft +collagen membrane
PROCEDURE	concentrated growth factor	intrabony defects treated by surgery and bone graft +concenrated growth factor membrane

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-07-01
• Completion: 2021-08-01
• First posted: 2021-08-12
• Last updated: 2021-09-17

Locations

1 site across 1 country: Egypt