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

Alveolar Ridge Preservation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05553548
• Other study ID #: 8722
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: January 10, 2024

Study information

• Verified date: September 2022
• Source: Cairo University
• Contact: nevein mohammed algammal, master
• Phone: 01126714444
• Email: nevein.osama[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: January 10, 2024
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Ridge Preservation

Intervention

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
• xenogenic bone graft in entire (apico-coronal) extension
xenogenic bone graft placed in the entire apico coronal extension and sealed with collagen plug

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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