Skip to main content
OpenTrials
Completed

NCT Number: NCT05001919

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

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..

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Malak Yousef Mohamed Shoukheba

Tanta, 20, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GTR

Procedure

intrabony defects treated by surgery and bone graft +collagen membrane

Other names: regenerative surgery

Concentrated growth factor

Procedure

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

Other names: regenerative surgery

Primary outcomes

  1. probing pocket depth

    Time frame: 12 months

    measured from the gingival margin to the base of the pocket using periodontal probe in mm

  2. clinical attachment level

    Time frame: 12months

    measured from the cemento-enamel junction to the base of the pocket using periodontal probe in mm

  3. radiographic defect area by cone beam x ray

    Time frame: 12 months

    measured in square millimeter from cone beam x ray

  4. radiographic bone density by cone beam

    Time frame: 12 months

    By Hounsfield unit from the cone beam x ray

Secondary outcomes

  1. bleeding on probing

    Time frame: 12 months

    bleeding on probing according to Ainamo and Bay1975

  2. gingival index

    Time frame: 12 months

    gingival index measured according to Loe and Silness 1963

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2021
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.