Clinical trial NCT05001919: Concentrated Growth Factors in Treatment of Intrabony Defects in Localized Aggressive Periodontitis
Official title: Concentrated Growth Factors Membrane in the Treatment of Intrabony Periodontal Defects in Localized Aggressive Periodontitis. A Randomized Controlled Split-Mouth Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Aggressive Periodontitis
Keywords: aggressive periodontitis
intrabony defect,
concentrated growth factors membrane
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: probing pocket depth
timeFrame: 12 months
measure: clinical attachment level
timeFrame: 12months
measure: radiographic defect area by cone beam x ray
timeFrame: 12 months
measure: radiographic bone density by cone beam
timeFrame: 12 months
Secondary outcomes:
measure: bleeding on probing
timeFrame: 12 months
measure: gingival index
timeFrame: 12 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Malak Yousef Mohamed Shoukheba
Study officials:
References: