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NCT Number: NCT07812883

Volumetric Efficacy of Alveolar Ridge Preservation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad del Desarrollo (UDD)

Santiago, Santiago Metropolitan, 7610315, Chile

Location status: Recruiting

Location contact

Claudio M Miranda, DDS

PRINCIPAL_INVESTIGATOR

Claudio m Claudio miranda, dds

CONTACT

[email protected]

+56 (2) 2327 9110

Dusan M Marinkovic, DDS

CONTACT

[email protected]

+56 (2) 2327 9110

Dusan M Marinkovic, DDS

SUB_INVESTIGATOR

Francisca c Collao, DDS

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spontaneous Healing

Procedure

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

d-PTFE Membrane

Procedure

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

Leukocyte- and Platelet-Rich Fibrin (L-PRF)

Procedure

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: L-PRF, Platelet-Rich Fibrin

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Postoperative Pain

    Time frame: 21 days after tooth extraction

    Patient-reported postoperative pain assessed using a 100-mm Visual Analogue Scale (VAS).

  3. 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.

  4. Keratinized Tissue Width

    Time frame: Baseline to 12 weeks after tooth extraction

    Change in the width of keratinized tissue measured clinically in millimeters.

  5. 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.

  6. Bleeding on probing

    Time frame: 12 and 24 months after implant loading

    Percentage of peri-implant sites presenting bleeding on probing.

  7. 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.

  8. Radiographic marginal bone level

    Time frame: 12 and 24 months after implant loading

    Mean marginal bone level measured radiographically in millimeters around implants.

Study contacts

Contact information is provided by the study sponsor or research team.

Claudio M Claudio Miranda, DDS, Director

CONTACT

[email protected]

+56 (2) 2327 9110

Dusan M Dusan Marinkovic, DDS

CONTACT

[email protected]

+56 (2) 2327 5256

Sponsors and collaborators

Lead sponsor

Universidad del Desarrollo

Other

Registry information

Official study title

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

Acronym: ARP

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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