Alveolar Ridge Preservation Using Bone Allografts With a PRF Membrane Versus GBR: A Randomized Controlled Clinical Trial.
Alveolar Ridge Preservation Using Bone Allografts With a PRF Membrane Versus GBR: A Randomized Controlled Clinical 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.
Study Overview
Status
Conditions
Detailed Description
Study Design
- Study Type: Interventional (Clinical Trial)
- Study Design: Prospective randomized controlled trial
- Estimated Enrollment: 51 participants
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single-blinded (Outcome Assessor)
- Primary Purpose: Treatment
Study Procedures
All study procedures will be performed according to a strictly standardized protocol and in a predefined chronological sequence to ensure the reliability and reproducibility of all measurements.
Preoperative Phase 1.1 Participant Eligibility Assessment
Clinical and Radiographic Examination
- Recording of complete medical and dental history.
- Comprehensive clinical examination and verification of the inclusion and exclusion criteria.
Informed Consent
Eligible participants will provide written informed consent before enrollment.
Randomization
Participants will be randomly allocated to one of the three treatment groups using a computer-generated randomization sequence.
Visit 1 (Baseline - Day of Tooth Extraction)
The following baseline measurements will be recorded:
- Width of keratinized tissue (using a UNC-15 periodontal probe; Hu-Friedy Group Coded #UNC CP-15).
- Gingival/mucosal thickness measured using an ultrasonic soft tissue device (Pirop®, Echoson, Krancowa, Poland).
- Standardized intraoral photographs of the site
1.2 Surgical Procedure
All surgical procedures will be performed under local anesthesia.
An atraumatic tooth extraction will be carried out using periotomes and elevators while avoiding flap elevation whenever possible.
Following extraction:
- Thorough debridement and curettage of the extraction socket.
- Verification of the integrity of all socket bony walls.
Group A - Spontaneous Healing
- No grafting material or barrier membrane will be placed.
- Stabilization of the blood clot using resorbable sutures (PGA 5-0). A figure-of-eight suture to create an H-shaped configuration over the membrane.
Group B - Allograft + Guided Bone Regeneration (GBR) Membrane
- Placement of particulate bone allograft up to the level of the alveolar crest (Corticocancellous Granules (0.25-1.0 mm), ALO580, 0.5 cc, Manufacturer: Cells + Tissuebank Austria CTBA, Magnesitstraße 1, 3500 Krems an der Donau, Austria)
- Placement of Resorbable Synthetic bilayer Barrier Membrane composed of poly(lactic-co-glycolic acid) (PLGA) (Septodont RTR+ Membrane®).
The membrane stabilises the soft tissues of the socket allowing healing by an open mode.
* Suturing of the soft tissues with a resorbable 5-0 polyglycolic acid (PGA) suture (Medipac, Greece), using a figure-of-eight suture to create an H-shaped configuration over the PLGA membrane.
Group C - Allograft + Platelet-Rich Fibrin (PRF) Membrane
- Collection of approximately 10 mL of venous blood before tooth extraction.
- Immediate centrifugation according to a standardized protocol.
- Preparation of the PRF membrane.
- Placement of particulate bone allograft as above (ALO580-CTBA) into the extraction socket and enrichment with injectable PRF (i-PRF).
- Placement of the PRF membrane over the socket entrance in a manner similar to the GBR membrane.
- Suturing of the soft tissues with a resorbable 5-0 polyglycolic acid (PGA) suture (Medipac, Greece), using a figure-of-eight suture to create an H-shaped configuration over the PRF membrane.
1.3 Radiographic Examination
The following radiographic examinations will be performed:
- Standardized periapical radiograph using the paralleling technique with a customized radiographic positioning guide.
- Cone Beam Computed Tomography (CBCT) for three-dimensional evaluation of the alveolar ridge dimensions using a customized reference stent.
Time points: day of the extraction and 3 months post-operatively.
Baseline radiographic examinations (performed immediately after tooth extraction) will be obtained exclusively for research purposes.
CBCT scans will be acquired on the day of extraction and at 3 months postoperatively, with the reference stent positioned identically at both time points.
A field of view (FOV) of 6 × 6 cm will be selected using high-resolution settings (voxel size: 150 μm, scan time: 9 seconds, tube voltage: 110 kV). All radiographic examinations will be performed using low-dose radiation according to the ALARA (As Low As Reasonably Achievable) principle. When necessary, an artifact reduction algorithm will be applied to improve image quality.
1.4 Postoperative Instructions
Participants will receive standardized postoperative instructions including:
* Oral hygiene instructions with avoidance of mechanical cleaning at the surgical site.
- No routine postoperative antibiotic prescription.
- Use of 0.12% chlorhexidine mouth rinse for 2 weeks.
- Analgesics as needed (ibuprofen 400 mg or paracetamol 500 mg).
- Recording of any postoperative complications.
- Distribution of a Visual Analog Scale (VAS) questionnaire for postoperative pain assessment.
Visit 2 (7 Days Postoperatively)
* Clinical evaluation of wound healing (visual clinical assessment).
- Collection of the completed VAS questionnaire.
- Assessment of healing and documentation of adverse events (inflammation, wound dehiscence, or graft/membrane exfoliation).
- Standardized intraoral photographs.
- Oral hygiene instructions.
Visit 3 (14 Days Postoperatively)
* Clinical evaluation of wound healing (visual clinical assessment).
- Assessment of healing and documentation of adverse events (inflammation, wound dehiscence, or graft/membrane exfoliation).
- Standardized intraoral photographs.
- Suture removal.
- Oral hygiene instructions
Visit 4 (6 Weeks Postoperatively)
* Clinical evaluation of wound healing (visual clinical assessment).
* Assessment of healing and documentation of adverse events (inflammation, wound dehiscence, or graft/membrane exfoliation).
* Standardized intraoral photographs.
* Oral hygiene instructions
Visit 5 (3 Months Postoperatively)
5.1 Clinical Measurements
* Width of keratinized tissue (using a UNC-15 periodontal probe; Hu-Friedy Group Coded #UNC CP-15).
* Gingival/mucosal thickness measured using an ultrasonic soft tissue device (Pirop®, Echoson, Krancowa, Poland).
* Standardized intraoral photographs.
5.2 Radiographic Measurements
* Standardized periapical radiograph.
* CBCT scan.
Measurements will include:
- Horizontal alveolar ridge width.
- Vertical alveolar ridge height changes.
Radiographic measurements will be performed by a blinded examiner using dedicated image-analysis software.
5. Definition of Variables and Outcome Measures
This randomized clinical trial will record demographic, clinical, and radiographic variables. Variables will be classified as independent (intervention), dependent (outcomes), and potential confounding variables.
1. Independent Variable
Type of Therapeutic Intervention
Nominal categorical variable.
Treatment groups:
- Spontaneous healing (Group A)
- Bone allograft + GBR membrane (Group B)
- Bone allograft + PRF membrane (Group C)
Allocation method:
Computer-generated randomization sequence.
2. Demographic Variables
Age
- Continuous variable.
- Unit: years.
- Recorded from the medical history.
Sex
* Nominal categorical variable.
* Categories: Male / Female.
Smoking Status
- Categorical variable.
- Categories:
- Non-smoker
- Light smoker (≤10 cigarettes/day)
Recorded from the medical history.
3. Primary Outcome
Changes in Alveolar Ridge Dimensions
Horizontal Ridge Width
- Continuous variable.
- Unit: millimeters (mm).
- Measured on CBCT images.
- Time points:
- Baseline (T0)
- Three months (T2)
- Outcome calculated as:
- T2 - T0.
Vertical Ridge Height
- Continuous variable.
- Unit: millimeters (mm).
- Measured on CBCT and standardized periapical radiographs.
- Change calculated between T0 and T2.
Measurement Tools
* Digital CBCT image-analysis software.
* Customized radiographic positioning guide to ensure reproducibility.
4. Secondary Outcomes
4.1 Gingival/Mucosal Thickness
- Continuous variable.
- Unit: millimeters.
- Measured using an ultrasonic soft tissue measuring device.
- Recorded at baseline and at 3 months.
4.2 Width of Keratinized Tissue
* Continuous variable.
- Unit: millimeters.
- Measured using a UNC-15 periodontal probe.
- Measured from the free gingival margin to the mucogingival junction.
- Recorded at baseline and at 3 months.
4.3 Early Wound Healing
* Visual wound-healing assessment.
- Buccolingual and mesiodistal wound dimensions (mm) will be recorded.
- Recorded immediately after extraction (baseline) and at 14 days.
- Clinical evaluation performed by a blinded examiner.
4.4 Changes in Clinical Attachment Level of Adjacent Teeth (Gingival Recession)
*Continuous variable.
- Unit: millimeters.
- Measured using a UNC-15 periodontal probe.
Distance measured from the cementoenamel junction (CEJ) to the free gingival margin.
- 5. Surgical/Procedural Variables
Surgical Time
* Continuous variable.
* Unit: minutes.
* Measured using a stopwatch.
Postoperative Complications
* Categorical variable.
- Categories: Yes / No.
Type of complication will be documented.
6. Measurement Reliability
- All measurements will be performed by a single calibrated examiner.
- Intra-examiner reliability will be assessed.
- The Intraclass Correlation Coefficient (ICC) will be calculated for radiographic measurements.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Thessaloniki
-
Thessaloniki, Thessaloniki, Greece, GR 54124
- Recruiting
- Aristotle University of Thessaloniki, School of Dentistry, Faculty of Health Sciences, Postgraduate Periodontology Department
-
Contact:
- Danae A Apatzidou, DDS, PhD, Professor
- Phone Number: +30 2310 999584
- Email: dapatzidou@dent.auth.gr
-
Contact:
- Konstantinos Papadimitriou, DDS, PhD, Assistant Professor
- Phone Number: (+30) 2310 999614
- Email: kpapadia@dent.auth.gr
-
Principal Investigator:
- Maria Laccotripe, DDS, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control group-Spontaneous healing
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).
|
Atraumatic tooth extraction and spontaneous healing.
|
|
Active Comparator: Bone Allograft + Resorbable Guided Bone Regeneration (GBR) Membrane
|
Atraumatic tooth extraction, placement of allograft (ALO580-CTBA) and barrier PLGA membrane Septodont RTR+ Membrane®)
|
|
Experimental: Bone Allograft + Autologous Platelet-Rich Fibrin (PRF) Membrane
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in alveolar ridge dimensions (height and width)
Time Frame: • Time Frame: Baseline (extraction) to 3 months
|
|
• Time Frame: Baseline (extraction) to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gingival (Mucosal) Thickness
Time Frame: Assessment time points: Baseline (T0) and 3 months postoperatively (T2).
|
Change in mucosal thickness Continuous quantitative variable. Measurement unit: millimeters (mm). Measurement method: Ultrasonic soft tissue thickness measurement device. |
Assessment time points: Baseline (T0) and 3 months postoperatively (T2).
|
|
Width of Keratinized Tissue
Time Frame: Assessment time points: Baseline (T0) and 3 months postoperatively (T2)
|
Continuous quantitative variable.
Measurement unit: millimeters (mm).
Measured using a UNC-15 periodontal probe.
Measured from the free gingival margin to the mucogingival junction.
|
Assessment time points: Baseline (T0) and 3 months postoperatively (T2)
|
|
Early Wound Healing
Time Frame: Assessments will be performed immediately following tooth extraction (baseline) and at 7 and 14 days postoperatively.
|
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. |
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)
Time Frame: Assessment time points: Baseline (T0) and 3 months postoperatively (T2).
|
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.
|
Assessment time points: Baseline (T0) and 3 months postoperatively (T2).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Majzoub Z, Cordioli G. Guided bone regeneration for alveolar ridge preservation: a systematic review. J Periodontol. 2017;88(5):541-50.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Bone Resorption
- Bone Diseases
- Musculoskeletal Diseases
- Periodontal Atrophy
- Periodontal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Pathologic Processes
- Disease Attributes
- Disease Progression
- Pathological Conditions, Signs and Symptoms
- Alveolar Bone Loss
- Remission, Spontaneous
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hypothalamic Hormones
- Peptide Hormones
- Neuropeptides
- Peptides
- Amino Acids, Peptides, and Proteins
- Nerve Tissue Proteins
- Proteins
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Control Groups
- Prolactin-Releasing Hormone
Other Study ID Numbers
- 323/29.04.2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.