Alveolar Ridge Changes With Biologically Oriented Alveolar Ridge Preservation (BARP) After Tooth Extraction

Alveolar Ridge Changes With Biologically Oriented Alveolar Ridge Preservation (BARP) After Tooth Extraction : A Randomized Clinical Trial

After tooth extraction, the alveolar process undergoes substantial horizontal and vertical resorption specifically in non-molar sites, where horizontal, vertical mid- facial, and mid-lingual ridge reduction could occur . These dimensional changes are clinically relevant, as they may affect dental implant placement and compromise soft tissue aesthetics.

Alveolar ridge preservation (ARP) is based on the application of a bone replacement graft into the extraction socket & collagen membrane/plug. Recent systematic reviews have shown that ARP may limit bone resorption to about 50% of what is normally observed in case of unassisted healing . This finding indicates that ARP is effective; but at the same time, it underlines the potential for improvement.

Study Overview

• Status: Not yet recruiting
• Conditions: Alveolar Ridge Preservation
• Intervention / Treatment: Procedure: biologically oriented alveolar ridge preservation; Procedure: xenogenic bone graft in entire (apico-coronal) extension

Detailed Description

In ARP procedures based on socket grafting, the use of a bone replacement graft would prevent up to a 30% of volume reduction in the coronal third. Whereas it has limited effect in the remaining middle-apical thirds . Since grafting of the alveolus often results in the persistence of residual graft particles embedded into the newly formed bone with a delay in the rate of bone deposition and mineralization the need to extend the grafting procedure apical to the coronal third of the socket seems questionable. Based on these considerations, a novel, simplified technique, namely, the Biologically-oriented Alveolar Ridge Preservation (BARP) for ARP that restricts socket grafting to the coronal portion of the socket was presented .

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: nevein mohammed algammal, master; Phone Number: 002 01126714444; Email: nevein.osama@dentistry.cu.edu.eg
• Study Contact Backup: Name: weam ahmed elbattawy, phd; Phone Number: 002 01001500537; Email: weamelbattawy@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 12613
      • Cairo University
      • Contact: weam ahmed elbattawy, phd; Phone Number: 002 01001500537; Email: weamelbattawy@dentistry.cu.edu.eg
      • Contact: nevein mohammed algammal, masters; Phone Number: 002 01126714444; Email: nevein.osama@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults 18 years old or more.
• Patients with good oral hygiene, defined as a full-mouth plaque score ≤25% (O'Leary et al., 1972).
• Patients who need alveolar ridge preservation after tooth extraction at one or two sites in the aesthetic zone (incisor, cuspid, or premolar area in the maxilla or mandible) with >50% buccal bone present following tooth extraction (Eeckhout et al., 2022) .
• One or two neighboring teeth.
• Compliant patients who will sign an informed consent and agree to the follow up period.

Exclusion Criteria:

• • Uncontrolled systemic disease

  • Past or current smoking
  • Untreated or unstable periodontitis
  • Untreated caries lesions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: biologically oriented alveolar ridge preservation (BARP) group; for alveolar ridge preservation using demineralized bovine bone graft layer in the most coronal part of the extracted tooth socket	Procedure: biologically oriented alveolar ridge preservation; xenogenic bone graft placed in coronal part of the non molar socket ,, collagen plug placed in appical part of socket and as socket seal
Active Comparator: bone graft (entire apico-coronal extension); alveolar ridge preservation using demineralized bovine bone graft on the entire apico-coronal extension.	Procedure: xenogenic bone graft in entire (apico-coronal) extension; xenogenic bone graft placed in the entire apico coronal extension and sealed with collagen plug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Horizontal radiographic changes in bone dimensions	Horizontal measurements will be performed perpendicular and parallel to the tooth axis, respectively. The level of the palatal bone crest preoperatively will be used as a reference line (level 0). The horizontal dimension of the alveolar process will be registered at 1, 3, and 5 mm apical to this reference line (level 1, 3, and 5). After performing all measurements on the CBCT (T1), the software switched to the superimposed image (T4) so that the measurements could be performed while using the same reference levels. Finally, changes in bone dimensions will be calculated by subtracting bone dimensions at T4 from that at T1.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertical radiographic changes in bone dimensions	Vertical measurement will be performed by measuring the height of buccal (B) and palatal (p) bone plates from the apical end of the socket to the coronal level of the socket.	4 months
Changes of soft tissue height at the buccal , lingual & central aspects of the site.	Since soft tissues will be separated from hard tissues by using lip retractors and a backward position of the tongue, soft tissue height could be assessed on CBCT images. Changes in soft tissue height will be calculated by subtracting soft tissue height at T4 from that at T1	4 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: nevein mohmmeda algammal, master, phd candidate (assistant lecturer)

Study record dates

Study Major Dates

• Study Start (Anticipated): October 20, 2022
• Primary Completion (Anticipated): January 5, 2023
• Study Completion (Anticipated): January 10, 2024

Study Registration Dates

• First Submitted: September 18, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 8722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: name: nevein mohammed osama algammal email : nevein.osama@dentistry.cu.edu.eg
• IPD Sharing Time Frame: after completion of the study
• 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