Bovine Bone With or Without Concentrated Growth Factor in the Treatment of Chronic Periodontitis

Comparative Study Between Bovine Bone With or Without Concentrated Growth Factor in the Treatment of Chronic Periodontitis

The aim of this study is to compare bovine bone with or without concentrated growth factor in the treatment of chronic periodontitis.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis; Concentrated Growth Factor; Bovine Bone
• Intervention / Treatment: Other: Concentrated growth factors, collagen membrane and xenograft bone graft; Other: Collagen membrane and xenograft bone graft

Detailed Description

Periodontitis is an infection-driven inflammatory disease resulting from dental plaque accumulation at the gingival margin, triggering an inflammatory response that leads to microbial alterations and may have severe consequences for the periodontium of susceptible individuals.

The xenograft most commonly used in periodontal regeneration procedures is the deproteinized bovine or equine bone mineral.

Platelets are known to play a significant role in guided tissue regeneration (GTR) by releasing several growth factors, such as platelet-derived growth factor (PDGF), and plasma rich in growth factors (PRGF), which are present in platelet-rich plasma (PRP), a first-generation platelet concentrate. Platelet-rich fibrin (PRF) and concentrated growth factors (CGF) are considered the second generation of platelet concentrate.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Presence of angular periodontal intra-bony defects with a pocket depth (PD) ≥ 5mm.
• Optimal compliance as evidenced by no missed treatment appointments and a positive attitude towards oral hygiene.
• Full-mouth bleeding score ≤ 25%.

Exclusion Criteria:

• Patients with relevant medical conditions that may affect periodontal regeneration and periodontal surgery.
• Patients who have any disease or take any medication that affects the normal number or function of platelets.
• Smokers.
• Pregnant or lactating women.
• Patients in whom periodontal surgery had previously been carried out on the selected site.
• Patients with aggressive periodontitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Ι; Ten sites were treated by concentrated growth factors (CGF), collagen membrane, and xenograft bone graft.	Other: Concentrated growth factors, collagen membrane and xenograft bone graft; Ten sites were treated by concentrated growth factors (CGF), collagen membrane, and xenograft bone graft.
Active Comparator: Group ΙΙ; Ten sites were treated with a collagen membrane and a xenograft bone graft.	Other: Collagen membrane and xenograft bone graft; Ten sites were treated with a collagen membrane and a xenograft bone graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Pocket depth	Probing Pocket depth (PPD) was measured.	6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level	Clinical attachment level (CAL) was measured.	6 months post-procedure
Bleeding on probing	Bleeding on probing (BOP) was measured.	6 months post-procedure
Plaque index	Plaque index (PI) was measured.	6 months post-procedure

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: July 31, 2025
• First Submitted That Met QC Criteria: July 31, 2025
• First Posted (Actual): August 7, 2025

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Periodontitis; Chronic Periodontitis; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: R-OMPDR-3-22-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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