Alveolar Ridge Changes With Biologically Oriented Alveolar Ridge Preservation (BARP) After Tooth Extraction : A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Horizontal radiographic changes in bone dimensions
Study 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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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
Intervention: biologically oriented alveolar ridge preservation (Procedure)
bone graft (entire apico-coronal extension)
alveolar ridge preservation using demineralized bovine bone graft on the entire apico-coronal extension.
Intervention: xenogenic bone graft in entire (apico-coronal) extension (Procedure)
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)
Investigators
Nevein Mohammed Osama Al-Gammal
Assisstant lecturer In periodontology department Future university in Egypt
Cairo University