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

Phase 1

Completed

• Conditions: Aggressive Periodontitis
• Interventions: Procedure: GTR; Procedure: concentrated growth factor

• Registration Number: NCT05001919
• Lead Sponsor: Tanta University

Brief 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.

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-08-01
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Presence of angular periodontal intra-bony defects with clinical attachment loss ≥5 mm measured from CEJ to the deepest propping depth with no evidence of gingival recession
• optimal compliance as evidenced by no missed treatment appointment and high attitude towards oral hygiene

Exclusion Criteria

• Patients with relevant medical conditions that may affect periodontal regeneration and surgery
• smokers, pregnant or lactating women
• those whom periodontal surgery had previously been carried out on the selected site,
• and patients who taking any drug known to affect the number or function of platelets

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
collagen membrane	GTR	10 sites treated with surgery and bone graft and collagen membrane as GTR
Concentrated growth factor membrane	concentrated growth factor	10 sites treated by surgery +bone graft and concentrated growth factor membrane as GTR

Primary Outcome Measures

Name	Time	Method
probing pocket depth	12 months	measured from the gingival margin to the base of the pocket using periodontal probe in mm
clinical attachment level	12months	measured from the cemento-enamel junction to the base of the pocket using periodontal probe in mm
radiographic defect area by cone beam x ray	12 months	measured in square millimeter from cone beam x ray
radiographic bone density by cone beam	12 months	By Hounsfield unit from the cone beam x ray

Secondary Outcome Measures

Name	Time	Method
bleeding on probing	12 months	bleeding on probing according to Ainamo and Bay1975
gingival index	12 months	gingival index measured according to Loe and Silness 1963

Trial Locations

Locations (1)

Malak Yousef Mohamed Shoukheba; 🇪🇬 Tanta, Egypt