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

NCT ID: NCT05001919

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-08-01

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.

Conditions

Aggressive Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

collagen membrane

10 sites treated with surgery and bone graft and collagen membrane as GTR

Group Type: PLACEBO_COMPARATOR

GTR

Intervention Type: PROCEDURE

intrabony defects treated by surgery and bone graft +collagen membrane

Concentrated growth factor membrane

10 sites treated by surgery +bone graft and concentrated growth factor membrane as GTR

Group Type: EXPERIMENTAL

concentrated growth factor

Intervention Type: PROCEDURE

intrabony defects treated by surgery and bone graft +concenrated growth factor membrane

Interventions

GTR

intrabony defects treated by surgery and bone graft +collagen membrane

Intervention Type: PROCEDURE

concentrated growth factor

intrabony defects treated by surgery and bone graft +concenrated growth factor membrane

Intervention Type: PROCEDURE

Other Intervention Names

regenerative surgery; regenerative surgery

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

malak mohamed shoukheba

associate prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Malak Yousef Mohamed Shoukheba

Tanta, , Egypt

Countries

Egypt

Other Identifiers

5

Identifier Type: -

Identifier Source: org_study_id