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

NCT07565558 | Completed

• 1 other identifier: PCN-1-133/K/2/K
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Alveolar Ridge Preservation; Socket Preservation; Xenograft; Allograft; Extraction Socket Healing

Keywords

Socket preservation; Alveolar Ridge Preservation; Extraction; Biomaterial; Oral surgery

Outcome Measures

Primary Outcomes (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.

  Day 7 to 180 days postoperatively

Secondary Outcomes (2)

• Change in optical Bone Density

  Day 7 to 180 days postoperatively

• Histological Evaluation

  180 days postoperatively

Study Arms (2)

Socket preservation utilizing a xenograft

ACTIVE COMPARATOR

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

Socket preservation utilizing an allograft

EXPERIMENTAL

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

Interventions

Socket preservation with xenograft PROCEDURE

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.

Also known as: Alveolar ridge preservation with xenograft

Socket preservation utilizing a xenograft

Socket preservation with allograft PROCEDURE

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.

Also known as: Alveolar ridge preservation with allograft

Socket preservation utilizing an allograft

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (2)

Department of Oral Surgery of the Medical University of Silesia in Bytom

Bytom, Silesian Voivodeship, 41-902, Poland

Location

"Comfortmed" dental clinic

Żory, Silesian Voivodeship, 44-240, Poland

Location

Related Publications (1)

• 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.

  PMID: 40558879 RESULT

MeSH Terms

Interventions

Transplantation, Heterologous; Transplantation, Homologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients are unaware of the type of biomaterial used during surgery. Radiographic and histological examinations are performed by trained, independent investigators who are not involved in the surgical procedures. The surgeon is not masked due to the nature of the surgical interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: August 5, 2024
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)