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Socket PreservationNCT07565558

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

A study testing Socket preservation with xenograft and Socket preservation with allograft in people with Socket Preservation and Alveolar Ridge Preservation, run by Medical University of Silesia at 2 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Socket preservation with xenograft and Socket preservation with allograft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesPoland
Study dates
5 Aug 2024to 27 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Poland2 sites
  • Department of Oral Surgery of the Medical University of Silesia in Bytom

    Bytom, Silesian Voivodeship, 41-902

  • "Comfortmed" dental clinic

    Żory, Silesian Voivodeship, 44-240

Other trials in Poland

About this study

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.

Read the 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.

Being tested
Socket preservation with xenograft, Socket preservation with allograft
Keywords
Socket preservation, Alveolar Ridge Preservation, Extraction, Biomaterial, Oral surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Socket preservation with xenograftProcedure or surgery

    Also called Alveolar ridge 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.

  • Socket preservation with allograftProcedure or surgery

    Also called Alveolar ridge 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.

Study groups in NCT07565558
Study groupRoleWhat they receive
Socket preservation utilizing a xenograftActive comparatorParticipants 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.
Receives: Procedure: Socket preservation with xenograft
Socket preservation utilizing an allograftExperimentalParticipants 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.
Receives: Procedure: Socket preservation with allograft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 7 to 180 days postoperatively

Secondary outcomes (2)
  1. 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.

    Measured: Day 7 to 180 days postoperatively

  2. 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.

    Measured: 180 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study start5 Aug 2024
  3. Primary completion27 Mar 2026
  4. Study completion27 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This prospective, randomized, parallel-group clinical study compares two bone substitute biomaterials that are suitable for the socket preservation technique. Eligible adult patients requiring the extraction of an unrestorable maxillary premolar or mandibular molar are allocated to either the xenograft group or the allograft group. The following procedures are carried out: extraction; debridement; socket preservation with the appropriate material, collagen membrane and suturing. All procedures are performed by the same experienced oral surgeon using standardised perioperative protocols. Clinical, histological, and radiographic outcomes are evaluated over an 180-day follow-up period.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07565558
Sponsor's protocol ID
PCN-1-133/K/2/K
Status last verified
Apr 2026
First submitted
27 Apr 2026
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 40558879

Questions about this trial

What is this clinical trial studying?

A study testing Socket preservation with xenograft and Socket preservation with allograft in people with Socket Preservation and Alveolar Ridge Preservation, run by Medical University of Silesia at 2 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the radiographic dimensions of the alveolar ridge. (time frame: Day 7 to 180 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07565558, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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