Comparative Analysis of 2 Bone Graft Materials in Socket Preservation

NCT ID: NCT07344025

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-04-30

Brief Summary

Socket preservation procedures after tooth extraction have been designed and implemented to maintain the volume of the bone and gingival tissues, which can decrease following the extraction of the teeth. In this clinical trial we will compare clinically and histologically the effectiveness of two distinct bovine bone graft materials; an allograft and a xenograft, in alveolar ridge preservation procedures following tooth extraction .

Detailed Description

Patients who seek socket preservation procedures will be identified and recruited from the out clinic of College of Dentistry. Inclusion criteria will be: systemically healthy, non-smoking patients aged 21-50 years, with no bone metabolism affecting medications, good oral hygiene (full-mouth plaque score <20%), and willingness to participate. Exclusion criteria included stage III/IV periodontitis, active periodontal lesions, acute infection, severely resorbed sockets (buccal bone height <5 mm), smoking >10 cigarettes/day, and pregnancy.

Indications for extraction include caries, failed endodontic treatment, unrestorable teeth, and tooth fracture. All patients underwent full periodontal examination and initial therapy (oral hygiene instructions, scaling, and root planing) at least 4 weeks before surgery. Preoperative CBCT scans will be analyzed for baseline conditions. Reference stents will be fabricated and used to standardize bone dimensional measurements.

Sample size estimation was based on detecting a mean dimensional change in ridge width following 2-3 months of healing. With SD = 10%, α = 0.05, and power = 80%, a minimum of 9 sockets per group (18 total) was deemed adequate.

Surgical Protocol All surgical procedures will be performed under local anesthesia (2% lidocaine with 1:100,000 epinephrine). A sulcular incision will be made with a 15c blade, and atraumatic extraction will be achieved using periotomes, tooth separation, and forceps while preserving the buccal plate. Following thorough socket debridement, the buccolingual ridge width will be measured using a periodontal probe and customized stent.

Patients will be randomly allocated into one of two treatment groups:

Group 1: Allograft group (n=9) Group 2: Xenograft group (n=9) In all cases, graft material will be condensed gently from the apical region. Sockets will be covered with a collagen membrane and closed with 4-0 PTFE sutures.

All patients will receive standard postoperative care including: amoxicillin 500 mg TID for 7 days, ibuprofen 600 mg BID, and 0.12% chlorhexidine rinse BID for 7 days (starting 48h post-op). Sutures will be removed after 14 days. Patients will be recalled at 2-3 months for CBCT scans with an identical machine and settings. Buccolingual ridge width and buccal bone thickness will be assessed by superimposing baseline and follow-up scans.

At 3 months, crestal/intrasulcular incisions will be made and flaps elevated for re-entry. Biopsies will be obtained using a 2.0-mm trephine bur (8 mm length) from all grafted sites. A total of 27 biopsies (9 per group) will be collected, coded, and fixed in 10% neutral buffered formalin. Osteotomies will be completed, and implants will be placed per manufacturer protocol.

Conditions

Socket Preservation; Alveolar Ridge Augmentation; Dental Implants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Allograft Group

Extraction sockets grafted with cortico-cancellous particulate allograft and covered with a collagen membrane.

Group Type: EXPERIMENTAL

Socket Preservation with Graft Material Allograft

Intervention Type: PROCEDURE

Socket preservation will be performed after tooth extraction using graft material Allograft or Xenograft according to standard surgical protocol.

Xenograft Group

Extraction sockets grafted with xenograft material and covered with a collagen membrane.

Group Type: EXPERIMENTAL

Socket Preservation with Graft Material Allograft

Intervention Type: PROCEDURE

Socket preservation will be performed after tooth extraction using graft material Allograft or Xenograft according to standard surgical protocol.

Interventions

Socket Preservation with Graft Material Allograft

Socket preservation will be performed after tooth extraction using graft material Allograft or Xenograft according to standard surgical protocol.

Intervention Type: PROCEDURE

Other Intervention Names

Socket Preservation with Graft Material Xenograft

Eligibility Criteria

Inclusion Criteria

• • Systemically healthy individuals

• Non-smokers
• Age between 21 and 50 years
• Indicated for tooth extraction and socket preservation
• Good oral hygiene (full-mouth plaque score <20%)
• Willingness to participate and provide informed consent

Exclusion Criteria

• • Stage III or IV periodontitis

• Active periodontal or periapical infection
• Severely resorbed sockets (buccal bone height <5 mm)
• Smoking more than 10 cigarettes per day
• Pregnancy
• Systemic conditions or medications affecting bone metabolism

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pharos University in Alexandria

OTHER

Sponsor Role: lead

Responsible Party

Haitham Sakr

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

H Sakr, PhD

Role: PRINCIPAL_INVESTIGATOR

Pharos university

Locations

College of Dentistry, Pharos University

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Haitham Sakr, PhD

Role: CONTACT

haitham.sakr@pua.edu.eg

3877700

Facility Contacts

Haitham Sakr, PhD

Role: primary

haitham.sakr@pua.edu.eg

3877700

Other Identifiers

PharosU

Identifier Type: -

Identifier Source: org_study_id