Volumetric Efficacy of Alveolar Ridge Preservation (ARP)

September 4, 2026 updated by: Universidad del Desarrollo

Comparative Efficacy of Three Alveolar Ridge Preservation Techniques for Volumetric Tissue Maintenance Following Tooth Extraction

The goal of this clinical trial is to compare the effectiveness of four post-extraction socket management approaches in preserving alveolar ridge dimensions following tooth extraction in adults requiring implant-supported rehabilitation in posterior regions.

The main questions it aims to answer are:

  • Which treatment approach provides the greatest preservation of hard- and soft-tissue dimensions 12 weeks after tooth extraction?
  • Does the use of a dense polytetrafluoroethylene (d-PTFE) membrane improve alveolar ridge preservation compared with approaches that do not use a membrane?
  • Are there differences among the treatment groups regarding postoperative healing, complications, pain, and bone regeneration?

Researchers will compare spontaneous socket healing, autologous blood clot with d-PTFE membrane, autologous blood clot with leukocyte- and platelet-rich fibrin (L-PRF), and autologous blood clot with L-PRF plus d-PTFE membrane to determine which approach provides the best preservation of alveolar ridge dimensions and tissue healing.

Participants will:

  • Undergo tooth extraction and be randomly assigned to one of four treatment groups.
  • Receive clinical examinations, intraoral scans, photographs, and cone-beam computed tomography (CBCT) imaging at scheduled follow-up visits.
  • Complete assessments of postoperative pain and oral health-related quality of life.
  • Undergo implant placement 12 weeks after tooth extraction, including collection of a bone biopsy for histomorphometric analysis.
  • Attend follow-up visits to evaluate peri-implant tissue health, marginal bone stability, and implant success up to 24 months after implant loading.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Alveolar ridge dimensional changes following tooth extraction are a well-documented biological phenomenon that may compromise future implant placement and prosthetic rehabilitation. These alterations are primarily associated with physiological bone modeling and remodeling processes, particularly affecting the buccal bone plate, which is often thin and highly susceptible to post-extraction resorption.

Alveolar ridge preservation (ARP) procedures have been developed to reduce post-extraction hard- and soft-tissue volume loss. Numerous techniques have been described, including the use of barrier membranes, platelet concentrates, and grafting materials. However, substantial controversy remains regarding the necessity of membrane utilization, the role of leukocyte- and platelet-rich fibrin (L-PRF), and the optimal approach for maintaining alveolar ridge dimensions while minimizing treatment complexity and costs.

Dense polytetrafluoroethylene (d-PTFE) membranes have been proposed as an effective barrier for preserving extraction socket architecture, whereas L-PRF has been suggested to enhance soft-tissue healing and tissue regeneration through the release of autologous growth factors. Despite the widespread clinical use of both approaches, evidence comparing these treatment strategies remains limited.

This randomized controlled clinical trial aims to compare four post-extraction socket management protocols: spontaneous healing, autologous blood clot combined with a d-PTFE membrane, autologous blood clot combined with L-PRF, and autologous blood clot combined with both L-PRF and a d-PTFE membrane. The study will evaluate their effects on hard- and soft-tissue dimensional preservation, clinical healing, postoperative outcomes, histomorphometric bone formation, patient-reported quality of life, and long-term implant-related outcomes.

The findings of this study are expected to contribute to the development of evidence-based protocols for alveolar ridge preservation and to improve clinical decision-making in implant dentistry.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Claudio M Claudio Miranda, DDS, Director
  • Phone Number: +56 (2) 2327 9110
  • Email: clmirandacar@gmail.com

Study Contact Backup

Study Locations

  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7610315
        • Recruiting
        • Universidad del Desarrollo (UDD)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claudio M Miranda, DDS
        • Sub-Investigator:
          • Francisca c Collao, DDS
        • Sub-Investigator:
          • Dusan M Marinkovic, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Requirement for tooth extraction with the possibility of subsequent implant-supported rehabilitation in the maxillary or mandibular premolar or molar regions.
  • Extraction sockets classified as Class I to Class Va according to the modified Cardaropoli classification.
  • American Society of Anesthesiologists (ASA) Physical Status I or II.
  • Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

  • Current treatment with bisphosphonates or systemic corticosteroids.
  • History of head and neck radiotherapy.
  • Metabolic bone disorders.
  • Teeth presenting with acute infectious pathology at the time of extraction.
  • Pregnancy or breastfeeding.
  • Inability or unwillingness to attend scheduled follow-up visits.
  • Any medical or psychological condition that, in the opinion of the investigators, could interfere with study participation or data interpretation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: Spontaneous Healing
Following atraumatic tooth extraction, the socket is left to heal spontaneously without the use of alveolar ridge preservation materials or barrier membranes.
Procedure: Spontaneous Healing
Following atraumatic tooth extraction, the extraction socket is left to heal naturally without the use of alveolar ridge preservation materials, grafting biomaterials, platelet concentrates, or barrier membranes. Healing occurs through spontaneous blood clot formation and physiological post-extraction tissue repair.
Other Names:
  • Unassisted Socket Healing
Experimental: Arm 2: Blood Clot + d-PTFE Membrane
Following atraumatic tooth extraction, the socket is allowed to fill with an autologous blood clot and is covered with a dense polytetrafluoroethylene (d-PTFE) membrane to promote alveolar ridge preservation.
Procedure: d-PTFE Membrane
Following atraumatic tooth extraction, the socket is allowed to fill with an autologous blood clot and is covered with a dense polytetrafluoroethylene (d-PTFE) membrane to protect the socket and support alveolar ridge preservation during healing
Experimental: Arm 3: Blood Clot + L-PRF
Following atraumatic tooth extraction, the socket is treated with autologous leukocyte- and platelet-rich fibrin (L-PRF) in combination with the natural blood clot to support tissue healing and alveolar ridge preservation.
Procedure: d-PTFE Membrane
Following atraumatic tooth extraction, the socket is allowed to fill with an autologous blood clot and is covered with a dense polytetrafluoroethylene (d-PTFE) membrane to protect the socket and support alveolar ridge preservation during healing
Procedure: Leukocyte- and Platelet-Rich Fibrin (L-PRF)
Autologous leukocyte- and platelet-rich fibrin (L-PRF) prepared from the participant's peripheral blood and placed within the extraction socket to promote tissue healing and support alveolar ridge preservation through the sustained release of growth factors.
Other Names:
  • Platelet-Rich Fibrin
  • L-PRF
Experimental: Blood Clot + L-PRF + d-PTFE Membrane
Following atraumatic tooth extraction, the socket is treated with autologous leukocyte- and platelet-rich fibrin (L-PRF) and covered with a dense polytetrafluoroethylene (d-PTFE) membrane to enhance tissue healing and alveolar ridge preservation.
Procedure: Leukocyte- and Platelet-Rich Fibrin (L-PRF)
Autologous leukocyte- and platelet-rich fibrin (L-PRF) prepared from the participant's peripheral blood and placed within the extraction socket to promote tissue healing and support alveolar ridge preservation through the sustained release of growth factors.
Other Names:
  • Platelet-Rich Fibrin
  • L-PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Alveolar Ridge Dimensions
Time Frame: 12 weeks after tooth extraction
Change in hard- and soft-tissue dimensions of the extraction site between baseline (T1) and 12 weeks after tooth extraction (T3), assessed through three-dimensional volumetric analysis using superimposed CBCT and intraoral scan datasets. Hard-tissue measurements include horizontal ridge width at 1, 3, and 5 mm apical to the alveolar crest (HW-1, HW-3, HW-5), buccal plate width, and socket depth. Soft-tissue measurements include tissue thickness at 1, 3, and 5 mm apical to the alveolar crest (TH-1, TH-3, TH-5) and total occlusal soft-tissue height.
12 weeks after tooth extraction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histomorphometric Bone Formation
Time Frame: 12 weeks after tooth extraction
Percentage of newly formed bone, residual biomaterial, and connective tissue/marrow spaces measured in bone biopsy specimens obtained during implant placement.
12 weeks after tooth extraction
Postoperative Pain
Time Frame: 21 days after tooth extraction
Patient-reported postoperative pain assessed using a 100-mm Visual Analogue Scale (VAS).
21 days after tooth extraction
Postoperative Complications
Time Frame: Up to 12 weeks after tooth extraction
Frequency and severity of soft-tissue dehiscence, membrane exposure or displacement, localized infection, and uncontrolled acute pain.
Up to 12 weeks after tooth extraction
Keratinized Tissue Width
Time Frame: Baseline to 12 weeks after tooth extraction
Change in the width of keratinized tissue measured clinically in millimeters.
Baseline to 12 weeks after tooth extraction
Oral Health-Related Quality of Life
Time Frame: Baseline to 24-28 weeks after tooth extraction
Change in Oral Health Impact Profile (OHIP-14) scores between baseline and definitive implant-supported restoration.
Baseline to 24-28 weeks after tooth extraction
Bleeding on probing
Time Frame: 12 and 24 months after implant loading
Percentage of peri-implant sites presenting bleeding on probing.
12 and 24 months after implant loading
Peri-implant probing depth
Time Frame: 12 and 24 months after implant loading
Mean peri-implant probing depth measured in millimeters using a calibrated periodontal probe.
12 and 24 months after implant loading
Radiographic marginal bone level
Time Frame: 12 and 24 months after implant loading
Mean marginal bone level measured radiographically in millimeters around implants.
12 and 24 months after implant loading

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad del Desarrollo

Investigators

  • Study Director: Francisca c Collao, DDS, Universidad del Desarrollo
  • Principal Investigator: Claudio M Miranda, dds, Universidad del Desarrollo
  • Study Chair: Dusan M Marinkovic, DDS, Universidad del Desarrollo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Marinkovic D, Collao F, Tello C, Miranda C, et al. (2025) Alveolar Ridge Preservation Using Clot and Dense Polytetrafluoroethylene Membrane (PTFE-d): A Novel Surgical Protocol and Clinical Case Report. Int J Oral Dent Health 11:173 doi.org/110.23937/2469-5734/1510173

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

September 4, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-115
  • IDREF Research Grants (Other Grant/Funding Number: International Congress of Oral Implantologists)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in publications arising from this study may be made available to qualified researchers upon reasonable request to the principal investigator. Data sharing will be subject to institutional approval, ethical considerations, and applicable data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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