Clinical trial NCT05553548: Alveolar Ridge Changes With Biologically Oriented Alveolar Ridge Preservation (BARP) After Tooth Extraction
Official title: Alveolar Ridge Changes With Biologically Oriented Alveolar Ridge Preservation (BARP) After Tooth Extraction : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Ridge Preservation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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.

Primary outcomes:
measure: Horizontal radiographic changes in bone dimensions
timeFrame: 4 months
Secondary outcomes:
measure: Vertical radiographic changes in bone dimensions
timeFrame: 4 months
measure: Changes of soft tissue height at the buccal , lingual & central aspects of the site.
timeFrame: 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
affiliation: phd candidate (assistant lecturer)
name: nevein mohmmeda algammal, master
role: PRINCIPAL_INVESTIGATOR
References: