Evaluation of the Effectiveness of the Socket Preservation Technique Using Allogeneic and Xenogeneic Materials

Tooth extraction is among the most common dental treatments. The procedure results in the formation of a bone defect. During the healing phase, the vertical and horizontal diameters of the alveolar ridge decrease, which has a negative impact on planned prosthetic or implantoprosthetic therapies.

The socket preservation technique involves filling the socket with an augmentation biomaterial to reduce vertical and horizontal alveolar atrophy. This prospective clinical study compares two biomaterials suitable for alveolar ridge preservation: xenogeneic versus allogeneic. Histological analysis and radiographic parameters related to the dimensions of the alveolar ridge and bone optical density are evaluated during a 180-day follow-up period.

Study Overview

• Status: Completed
• Conditions: Socket Preservation; Allograft; Alveolar Ridge Preservation; Extraction Socket Healing; Xenograft
• Intervention / Treatment: Procedure: Socket preservation with xenograft; Procedure: Socket preservation with allograft

Detailed Description

Tooth extraction is among the most frequently conducted procedures in the field of dentistry. The immediate result of this procedure is the formation of a bone defect that becomes occupied by a blood clot. The healing process of the socket is complex and unfolds over several stages, extending for many months or even years. Throughout this duration, there is a noticeable decrease in both the vertical and horizontal dimensions of the alveolar ridge. This reduction in volume can negatively impact any planned prosthetic or implantoprosthetic treatment. One of the numerous factors that influence the healing of the alveolar ridge is the thickness of the buccal bone plate. Sockets that possess a thin buccal bone plate (less than 1mm) are particularly susceptible to dimensional changes during the healing phase.

The technique of socket preservation, which involves filling the socket with an augmentation biomaterial, mitigates alveolar atrophy. The biomaterial placed within the socket serves as a scaffold that aids in stabilizing and maturing the blood clot during the initial phases of healing, while also facilitating the development of new bone by osteoblasts in the subsequent stages.

A variety of materials can be utilized for socket preservation, including autogenous bone, allogeneic bone, xenogeneic bone, and alloplastic materials. Each of these materials possesses distinct properties, which include osteoconduction, osteoinduction, and osteogenesis.

Osteoconduction refers to the capacity of a material to create a framework for the development of new bone tissue. Osteoinduction denotes the capability of a biomaterial to encourage undifferentiated mesenchymal cells to transform into osteoblasts, thus promoting bone formation. Osteogenesis is defined as the ability of living cells within the augmentation material to produce new bone.

Xenografts are biological materials derived from animal sources that demonstrate solely osteoconductive properties. These grafts are created from bone that has been meticulously processed to eliminate its organic elements and minimize immunogenic responses, resulting in a mineral framework predominantly made up of hydroxyapatite. Although bovine-derived materials (e.g., Bio-Oss®) are the most frequently utilized, alternatives from various other species are also accessible.

Allogeneic bone grafts are sourced from either living donors or cadavers and are subjected to processing techniques such as freeze-drying (FDBA) or demineralization (DFDBA). These methods aim to eliminate immunogenic elements while retaining the mineral and collagen matrix. Freeze-dried bone allografts possess mainly osteoconductive properties, in contrast to demineralized freeze-dried bone allografts, which exhibit both osteoconductive and osteoinductive properties due to the exposure of bone morphogenetic proteins (BMPs) during the demineralization process. The removal of the mineral component, however, compromises the volumetric stability of the graft. To attain osteoinductive potential while preserving volumetric stability, a partial demineralization of the allograft can be executed, resulting in a material with intermediate characteristics (e.g., BioBank®).

This prospective, randomised comparative clinical investigation is designed to evaluate two biomaterials used in the socket preservation technique. Adult patients presenting with an unrestorable maxillary premolar or mandibular molar are screened for eligibility and randomly assigned to one of two groups according to the augmentation material, using Research Randomizer software (https://www.randomizer.org/).

In the experimental group, socket preservation is performed using an allogeneic material (BIOBank®, cortico-cancellous bone powder, 0.5 mm granules). In the control group, socket preservation is performed using a xenogeneic material (Geistlich Bio-Oss®, 0.25-1 mm granules). A collagen membrane (Geistlich Bio-Gide®) is used to cover the socket in all patients, and it is stabilized with nylon 4-0 sutures.

The dimensional alteration of the alveolar ridge and the optical density of the bone are measured by superimposing cone-beam computed tomography (CBCT) scans with a field of view (FOV) of 5 x 5 cm, taken 7-10 and 180 days after surgery. Histological analysis is performed on bone biopsies taken with a trephine during implant surgery. Both groups received standardised perioperative management, including socket debridement, pharmacotherapy and scheduled postoperative follow-up.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Silesian Voivodeship
    • Bytom, Silesian Voivodeship, Poland, 41-902
      • Department of Oral Surgery of the Medical University of Silesia in Bytom
    • Żory, Silesian Voivodeship, Poland, 44-240
      • "Comfortmed" dental clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Maxillary premolar or mandibular molar unsuitable for restorative treatment
• Vestibular lamina width of less than 1 mm
• Age between 18 and 65 years
• Absence of vestibular lamina defects, such as fenestrations or dehiscences
• Ability and willingness to attend scheduled follow-up visits
• Provision of written informed consent

Exclusion Criteria:

• Alcoholism
• Nicotine addiction
• Immunosuppressive medications
• Systemic diseases that could affect the healing of soft or hard tissues
• Chemotherapy or radiation therapy to the head and neck region within the past 5 years
• Poor oral hygiene
• Extensive tooth loss

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Socket preservation utilizing a xenograft; Participants requiring the extraction of a maxillary premolar or mandibular molar who are otherwise eligible for this study undergo a minimally invasive procedure consisting of tooth extraction with separation, wound debridement and socket preservation using xenogeneic biomaterial (Geistlich Bio-Oss®, cortico-cancellous bone powder, 0.25-1 mm granules) with a Geistlich Bio-Gide® collagen membrane and 4-0 nylon sutures. An open healing protocol is utilised. Standardised postoperative care, antibiotics and follow-up are provided. CBCT with a 5x5 cm field of view is performed preoperatively and at 7-10 and 180 days post-treatment.	Procedure: Socket preservation with xenograft; Minimally invasive tooth extraction with separation is performed. The wound is debrided and the socket is filled with xenogeneic biomaterial (Geistlich Bio-Oss®, cortico-cancellous bone powder, 0.25-1 mm granules) up to the alveolar crest. This is then covered with a Geistlich Bio-Gide® collagen membrane and sutured with 4-0 nylon sutures. An open healing protocol is utilised. Standardised postoperative care, antibiotics and follow-up are provided. CBCT scans with a 5x5 cm field of view are performed preoperatively, and again after 7-10 days and after 180 days of treatment.; Other Names: Alveolar ridge preservation with xenograft
Experimental: Socket preservation utilizing an allograft; Participants requiring the extraction of a maxillary premolar or mandibular molar who are otherwise eligible for this study undergo a minimally invasive procedure consisting of tooth extraction with separation, wound debridement and socket preservation using allogeneic biomaterial (BIOBank®, cortico-cancellous bone powder, 0.5 mm granules) with a Geistlich Bio-Gide® collagen membrane and 4-0 nylon sutures. An open healing protocol is utilised. Standardised postoperative care, antibiotics and follow-up are provided. CBCT with a 5x5 cm field of view is performed preoperatively and at 7-10 and 180 days post-treatment.	Procedure: Socket preservation with allograft; Minimally invasive tooth extraction with separation is performed. The wound is debrided and the socket is filled with allogeneic biomaterial (BIOBank®, cortico-cancellous bone powder, 0.5 mm granules) up to the alveolar crest. This is then covered with a Geistlich Bio-Gide® collagen membrane and sutured with 4-0 nylon sutures. An open healing protocol is utilised. Standardised postoperative care, antibiotics and follow-up are provided. CBCT scans with a 5x5 cm field of view are performed preoperatively, and again after 7-10 days and after 180 days of treatment.; Other Names: Alveolar ridge preservation with allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the radiographic dimensions of the alveolar ridge.	The primary outcome is the change of alveolar ridge width and height measured 7 days and 6 months post-surgery. Image superimposition is performed using Planmeca's Romexis software. Measurements are taken in the sagittal plane. For the premolar group, measurements are taken in the central part of the alveolar socket. For the molar group, measurements are taken in the central part of the alveolar socket of the mesial root. Alveolar socket width measurements are taken at the alveolar crest, at the bottom of the alveolus and at the midpoint between these two points. Height is measured from the bottom of the alveolus to the top of the respective buccal or palatal/lingual bony plates. The smaller the change in alveolar width and height, the more favourable it is for future prosthetic or implant treatment.	Day 7 to 180 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in optical Bone Density	The optical bone density of the augmented alveolar socket is evaluated using the ImageJ software (version 1.54p, Wayne Rasband and contributors, National Institutes of Health, USA) on sagittal cone-beam computed tomography (CBCT) scans. Measurements are taken at 7 and 180 days post-operatively and are expressed in Hounsfield units (HU). For each patient, a uniform ROI measuring 50 x 50 pixels is selected. Greater optical bone density indicates higher expected primary stability of the implant.	Day 7 to 180 days postoperatively
Histological Evaluation	Bone biopsy specimens taken from the augmented area and intended for histochemical analysis are fixed immediately in a 4% buffered formaldehyde solution. After decalcification in 12% EDTA for seven days, they undergo the standard paraffin embedding procedure in the Department of Histology and Cell Pathology. The paraffin blocks are then sectioned into 5 µm thick slices using a rotary microtome. The sections are stained with haematoxylin and eosin (H&E), as well as Masson's trichrome stain. H&E staining enables visualisation of the tissue sample's microstructure, cells and morphological aspects. Masson's trichrome staining enables differentiation between non-mineralized collagen (stained blue) and mineralized collagen (stained red), allowing distinction between woven bone and mature lamellar bone.	180 days postoperatively

Collaborators and Investigators

• Sponsor: Medical University of Silesia

Publications and helpful links

General Publications

• Wrobel P, Piecuch A, Bak M, Krynicki P, Adamczyk J, Mojzesz P, Kielbon A, Wojcik S, Starosta M, Lee WP, Morawiec T. Evaluation of the Effectiveness of the Socket Preservation Technique Using Allogeneic and Xenogeneic Materials-A Preliminary Study. J Funct Biomater. 2025 May 23;16(6):192. doi: 10.3390/jfb16060192.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Actual): March 27, 2026
• Study Completion (Actual): March 27, 2026

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Alveolar Ridge Preservation; Socket preservation; Biomaterial; Oral surgery; Extraction
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Transplantation; Transplantation, Heterologous; Transplantation, Homologous
• Other Study ID Numbers: PCN-1-133/K/2/K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No