A Phase 1/2 interventional study of GTR and concentrated growth factor in Aggressive Periodontitis, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Tanta University · Phase 1/2, Interventional, and Treatment
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..
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 10 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
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Exclusion Criteria:
10 sites treated with surgery and bone graft and collagen membrane as GTR
Procedure: GTR
10 sites treated by surgery +bone graft and concentrated growth factor membrane as GTR
Procedure: concentrated growth factor
intrabony defects treated by surgery and bone graft +collagen membrane
Also known as: regenerative surgery
intrabony defects treated by surgery and bone graft +concenrated growth factor membrane
Also known as: regenerative surgery
probing pocket depth
measured from the gingival margin to the base of the pocket using periodontal probe in mm
Time frame: 12 months
clinical attachment level
measured from the cemento-enamel junction to the base of the pocket using periodontal probe in mm
Time frame: 12months
radiographic defect area by cone beam x ray
measured in square millimeter from cone beam x ray
Time frame: 12 months
radiographic bone density by cone beam
By Hounsfield unit from the cone beam x ray
Time frame: 12 months
bleeding on probing
bleeding on probing according to Ainamo and Bay1975
Time frame: 12 months
gingival index
gingival index measured according to Loe and Silness 1963
Time frame: 12 months
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Tanta University