Concentrated Growth Factors in Treatment of Intrabony Defects in Localized Aggressive Periodontitis (RCT)

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

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..

Study Overview

• Status: Completed
• Conditions: Aggressive Periodontitis
• Intervention / Treatment: Procedure: GTR; Procedure: concentrated growth factor

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 20
    • Malak Yousef Mohamed Shoukheba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: collagen membrane; 10 sites treated with surgery and bone graft and collagen membrane as GTR	Procedure: GTR; intrabony defects treated by surgery and bone graft +collagen membrane; Other Names: regenerative surgery
EXPERIMENTAL: Concentrated growth factor membrane; 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 +concenrated growth factor membrane; Other Names: regenerative surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ACTUAL): July 1, 2021
• Study Completion (ACTUAL): August 1, 2021

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (ACTUAL): August 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: aggressive periodontitis; intrabony defect,; concentrated growth factors membrane
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Aggression; Periodontitis; Aggressive Periodontitis; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: 5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No