Different Approaches for Alveolar Ridge Preservation

NCT07818447 | Recruiting DMC

• 1 other identifier: 323/29.04.2026
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Following tooth extraction, physiologic remodeling of the alveolar ridge results in significant horizontal and vertical bone resorption, often accompanied by soft tissue collapse. These dimensional changes may complicate future implant placement and compromise esthetic and functional outcomes. Alveolar ridge preservation techniques have been introduced to limit post-extraction tissue loss by supporting bone regeneration and stabilizing the soft tissues. A previously conducted study has shown optimal wound healing of a guided bone regeneration technique by employing a non-submerged barrier membrane versus a socket seal technique employing a free gingival graft versus unassisted healing. This prospective randomized controlled clinical trial aims to evaluate the effectiveness of alveolar ridge preservation using the combination of an allograft with either a platelet-rich fibrin (PRF) membrane, versus combination of an allograft with a barrier membrane versus spontaneous healing after tooth extraction. A total of fifty-one subjects will be randomly allocated into three treatment groups. Clinical and radiographic (periapical radiograph, CBCT) outcomes will be assessed at baseline, and 3 months post-extraction.

Conditions

Alveolar Ridge Resorption

Keywords

socket seal; randomized controlled clinical trial; alveolar ridge preservation; socket preservation; polylactic-glycolic acid membrane; synthetic membrane; spontaneous healing; natural healing; unassisted healing; allograft; barrier membrane; PRF membrane; alveolar bone resorption; tooth extraction

Outcome Measures

Primary Outcomes (1)

• Change in alveolar ridge dimensions (height and width)

  1. Horizontal Alveolar Ridge Width Continuous quantitative variable. Measurement unit: millimeters (mm). Assessed using cone beam computed tomography (CBCT). Assessment time points: Baseline (T0; Visit 1) and 3 months postoperatively (T2). Outcome measure: Change in horizontal ridge width, calculated as T2 - T0. 2. Vertical Alveolar Ridge Height Continuous quantitative variable. Measurement unit: millimeters (mm). Assessed using CBCT and standardized periapical radiographs. Outcome measure: Change in vertical ridge height from T0 to T2. Measurement Tools Digital CBCT image analysis software. Standardized radiographic positioning guide to ensure reproducibility of radiographic measurements.

  • Time Frame: Baseline (extraction) to 3 months

Secondary Outcomes (4)

• Gingival (Mucosal) Thickness

  Assessment time points: Baseline (T0) and 3 months postoperatively (T2).

• Width of Keratinized Tissue

  Assessment time points: Baseline (T0) and 3 months postoperatively (T2)

• Early Wound Healing

  Assessments will be performed immediately following tooth extraction (baseline) and at 7 and 14 days postoperatively.

• Changes in the Clinical Attachment Level of Adjacent Teeth (Gingival Recession)

  Assessment time points: Baseline (T0) and 3 months postoperatively (T2).

Study Arms (3)

Control group-Spontaneous healing

OTHER

Participants will undergo atraumatic tooth extraction followed by spontaneous socket healing without the placement of any grafting material or barrier membrane. Routine treatment of the extraction socket. Extraction of the tooth and suturing of the soft tissues with resorbable suture PGA 5/0 (polygalactic acid 5/0 sutures; PGA, medipac, Greece).

Other: Control group

Bone Allograft + Resorbable Guided Bone Regeneration (GBR) Membrane

ACTIVE COMPARATOR

* Atraumatic tooth extraction and socket debridement * Placement of particulate bone allograft (ALO580-CTBA)into the extraction socket up to the level of the crestal bone * Seal the socket orifice with a PLGA barrier membrane (Septodont RTR+ Membrane®) applied onto the crestal bone under the mucosal margins of the socket allowing healing by an open mode * Suturing using resorbable sutures (PGA 5/0) (Medipac, Greece) without necessarily achieving primary wound closure

Procedure: Bone Allograft + Resorbable Guided Bone Regeneration Membrane

Bone Allograft + Autologous Platelet-Rich Fibrin (PRF) Membrane

EXPERIMENTAL

* Atraumatic tooth extraction and socket debridement * Placement of particulate bone allograft (ALO580-CTBA)as above into the extraction socket * Preparation of autologous PRF according to standardized centrifugation protocol; application of a PRF membrane applied over the socket opening in an identical manner as the barrier membrane * Resorbable sutures (PGA 5/0) (Medipac, Greece) without necessarily achieving primary wound closure

Procedure: Bone Allograft + Autologous Platelet-Rich Fibrin (PRF) Membrane

Interventions

Bone Allograft + Autologous Platelet-Rich Fibrin (PRF) Membrane PROCEDURE

Preparation of the PRF membrane. Placement of particulate bone allograft (ALO580-CTBA) and enrichment with injectable PRF (i-PRF). Placement of the PRF membrane over the socket entrance in a manner similar to the GBR membrane.

Bone Allograft + Autologous Platelet-Rich Fibrin (PRF) Membrane

Control group OTHER

Atraumatic tooth extraction and spontaneous healing.

Control group-Spontaneous healing

Bone Allograft + Resorbable Guided Bone Regeneration Membrane PROCEDURE

Atraumatic tooth extraction, placement of allograft (ALO580-CTBA) and barrier PLGA membrane Septodont RTR+ Membrane®)

Bone Allograft + Resorbable Guided Bone Regeneration (GBR) Membrane

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Requirement for extraction of a single tooth affected by periodontal disease.
• Presence of at least one adjacent tooth.
• Loss of the buccal alveolar bone wall involving up to 50% of the socket wall.
• Good general systemic health (American Society of Anesthesiologists ASA Physical Status I or II).
• Satisfactory oral hygiene.
• Ability to understand the study procedures and provide written informed consent.

You may not qualify if:

• Systemic diseases or medications known to affect bone or soft tissue healing (e.g., uncontrolled diabetes mellitus, osteoporosis treated with bisphosphonates, or immunosuppressive therapy).
• Heavy smoking (\>10 cigarettes/day).
• Pregnancy or breastfeeding.
• Presence of an acute infection or abscess at the extraction site.
• History of radiotherapy to the head and neck region.
• Inability or unwillingness to comply with the study protocol or attend scheduled follow-up visits.

Sponsors & Collaborators

• Danae A. Apatzidou: lead

Study Sites (1)

Aristotle University of Thessaloniki, School of Dentistry, Faculty of Health Sciences, Postgraduate Periodontology Department

Thessaloniki, Thessaloniki, GR 54124, Greece

RECRUITING

Related Publications (4)

• Majzoub Z, Cordioli G. Guided bone regeneration for alveolar ridge preservation: a systematic review. J Periodontol. 2017;88(5):541-50.

  BACKGROUND

• Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25.

  PMID: 24966231 BACKGROUND

• Annunziata M, Guida L, Nastri L, Piccirillo A, Sommese L, Napoli C. The Role of Autologous Platelet Concentrates in Alveolar Socket Preservation: A Systematic Review. Transfus Med Hemother. 2018 May;45(3):195-203. doi: 10.1159/000488061. Epub 2018 May 3.

  PMID: 29928175 BACKGROUND

• Maiorana C, Poli PP, Deflorian M, Testori T, Mandelli F, Nagursky H, Vinci R. Alveolar socket preservation with demineralised bovine bone mineral and a collagen matrix. J Periodontal Implant Sci. 2017 Aug;47(4):194-210. doi: 10.5051/jpis.2017.47.4.194. Epub 2017 Aug 11.

  PMID: 28861284 BACKGROUND

MeSH Terms

Conditions

Remission, Spontaneous

Interventions

Prolactin-Releasing Hormone; Control Groups

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS, PhD, Professor, Head of the Department, Director of the EFP accredited PG program "Periodontology & Implant Biology", Dept. of Preventive Dentistry, Periodontology & Implant Biology, School of Dentistry, Aristotle University of Thessaloniki

Model Details: Randomised controlled clinical trial having 3 parallel intervention arms for alveolar ridge preservation and prevention of future alveolar bone resorption due to volumetric changes of tissues post-tooth extraction.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)