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Clinical Trials/NCT05553548
NCT05553548
Not yet recruiting
Not Applicable

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

Cairo University1 site in 1 country36 target enrollmentOctober 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alveolar Ridge Preservation
Sponsor
Cairo University
Enrollment
36
Locations
1
Primary Endpoint
Horizontal radiographic changes in bone dimensions
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief 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.

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 .

Registry
clinicaltrials.gov
Start Date
October 20, 2022
End Date
January 10, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nevein Mohammed Osama Al-Gammal

Assisstant lecturer In periodontology department Future university in Egypt

Cairo University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Horizontal radiographic changes in bone dimensions

Time Frame: 4 months

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.

Secondary Outcomes

  • Changes of soft tissue height at the buccal , lingual & central aspects of the site.(4 months)
  • Vertical radiographic changes in bone dimensions(4 months)

Study Sites (1)

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