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NCT Number: NCT07344025

Comparative Analysis of 2 Bone Graft Materials in Socket Preservation

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 .

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry, Pharos University

Alexandria, Egypt

Location status: Recruiting

Location contact

Haitham Sakr, PhD

CONTACT

[email protected]

3877700

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Socket Preservation with Graft Material Allograft

Procedure

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

Other names: Socket Preservation with Graft Material Xenograft

Primary outcomes

  1. Change in buccolingual ridge width

    Time frame: Baseline to 2-3 months

    Difference in ridge width measured clinically and radiographically between baseline and 2-3 months post-extraction

Secondary outcomes

  1. Histomorphometric outcomes

    Time frame: 2-3 months

    Percentage of new bone formation, residual graft material, and soft tissue/marrow space

Study contacts

Contact information is provided by the study sponsor or research team.

Haitham Sakr, PhD

CONTACT

[email protected]

3877700

Sponsors and collaborators

Lead sponsor

Pharos University in Alexandria

Other

Registry information

Official study title

Comparative Analysis of Healing Outcomes Between Two Bone Graft Materials in Socket Preservation Procedure

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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