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

NCT05553548 | Unknown

• 1 other identifier: 8722
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Ridge Preservation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Vertical radiographic changes in bone dimensions

  4 months

• Changes of soft tissue height at the buccal , lingual & central aspects of the site.

  4 months

Study Arms (2)

biologically oriented alveolar ridge preservation (BARP) group

EXPERIMENTAL

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

bone graft (entire apico-coronal extension)

ACTIVE COMPARATOR

alveolar ridge preservation using demineralized bovine bone graft on the entire apico-coronal extension.

Procedure: xenogenic bone graft in entire (apico-coronal) extension

Interventions

biologically oriented alveolar ridge preservation PROCEDURE

xenogenic bone graft placed in coronal part of the non molar socket ,, collagen plug placed in appical part of socket and as socket seal

biologically oriented alveolar ridge preservation (BARP) group

xenogenic bone graft in entire (apico-coronal) extension PROCEDURE

xenogenic bone graft placed in the entire apico coronal extension and sealed with collagen plug

bone graft (entire apico-coronal extension)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Uncontrolled systemic disease
• Past or current smoking
• Untreated or unstable periodontitis
• Untreated caries lesions.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 12613, Egypt

Location

Study Officials

• nevein mohmmeda algammal, master

  phd candidate (assistant lecturer)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

nevein mohammed algammal, master

CONTACT

01126714444; nevein.osama@dentistry.cu.edu.eg

Weam ahmed ElBattawy, phd

CONTACT

01001500537; weamelbattawy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer In periodontology department Future university in Egypt

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: September 23, 2022
• Study Start: October 20, 2022
• Primary Completion: January 5, 2023
• Study Completion: January 10, 2024
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after completion of the study

Locations

EG (1)