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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Aggressive Periodontitis

Intervention / Treatment
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* Procedure: GTR
* Procedure: concentrated growth factor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Twenty intra-bony defects in 10 patients were randomly assigned to either test or control group in split-mouth technique (10 sites in each group).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: collagen membrane<br>10 sites treated with surgery and bone graft and collagen membrane as GTR | Procedure: GTR<br>* intrabony defects treated by surgery and bone graft +collagen membrane<br>* Other names: regenerative surgery;|
| Experimental: Concentrated growth factor membrane<br>10 sites treated by surgery +bone graft and concentrated growth factor membrane as GTR | Procedure: concentrated growth factor<br>* intrabony defects treated by surgery and bone graft +concenrated growth factor membrane<br>* Other names: regenerative surgery;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding on probing | bleeding on probing according to Ainamo and Bay1975 | 12 months | 
| gingival index | gingival index measured according to Loe and Silness 1963 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aggressive periodontitis, intrabony defect,, concentrated growth factors membrane