Health TrialsbyHealthPanel

Different Approaches for Alveolar Ridge Preservation

ConditionAlveolar Ridge Resorption
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDanae A. Apatzidou

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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.

  • Control group

    Other intervention

    Atraumatic tooth extraction and spontaneous healing.

  • Bone Allograft + Resorbable Guided Bone Regeneration Membrane

    Procedure/Surgery

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

Treatment groups

51 Participants
are divided into 3 treatment groups
Group A: Control group-Spontaneous healingOther 1 intervention
Group B: Bone Allograft + Resorbable Guided Bone Regeneration (GBR) MembraneActive comparator 1 intervention
Group C: Bone Allograft + Autologous Platelet-Rich Fibrin (PRF) MembraneExperimental treatment 1 intervention

Trial outcomes

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
• Time Frame: Baseline (extraction) to 3 months

Secondary outcomes

1

Gingival (Mucosal) Thickness

Change in mucosal thickness Continuous quantitative variable. Measurement unit: millimeters (mm). Measurement method: Ultrasonic soft tissue thickness measurement device.

Time frame
Assessment time points: Baseline (T0) and 3 months postoperatively (T2).
2

Width of Keratinized Tissue

Continuous quantitative variable. Measurement unit: millimeters (mm). Measured using a UNC-15 periodontal probe. Measured from the free gingival margin to the mucogingival junction.

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

Early Wound Healing

Clinical wound healing will be assessed using a visual wound healing assessment. Buccolingual and mesiodistal wound dimensions (mm) will be recorded. All clinical evaluations will be performed by a blinded examiner.

Time frame
Assessments will be performed immediately following tooth extraction (baseline) and at 7 and 14 days postoperatively.
4

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

Continuous quantitative variable. Measurement unit: millimeters (mm). Measured using a UNC-15 periodontal probe. Clinical attachment level will be measured as the distance from the cementoenamel junction (CEJ) to the free gingival margin.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Danae A. Apatzidou

Lead sponsor

Aristotle University Of Thessaloniki

Sponsor institution

Source ClinicalTrials.gov
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