Volumetric Efficacy of Alveolar Ridge Preservation

NCT07812883 | Recruiting

• 2 other identifiers: 2025-115IDREF Research Grants
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alveolar Ridge Preservation; Tooth Loss; Tooth Extraction; Tooth Extraction Site Healing; Alveolar Ridge Resorption After Extraction

Keywords

Alveolar Ridge Preservation; Tooth Extraction; Extraction Socket; Socket Preservation; d-PTFE Membrane; Dense Polytetrafluoroethylene Membrane; Leukocyte- and Platelet-Rich Fibrin; L-PRF; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in Alveolar Ridge Dimensions

  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 Outcomes (8)

• Histomorphometric Bone Formation

  12 weeks after tooth extraction

• Postoperative Pain

  21 days after tooth extraction

• Postoperative Complications

  Up to 12 weeks after tooth extraction

• Keratinized Tissue Width

  Baseline to 12 weeks after tooth extraction

• Oral Health-Related Quality of Life

  Baseline to 24-28 weeks after tooth extraction

Study Arms (4)

Spontaneous Healing

ACTIVE COMPARATOR

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

Arm 2: Blood Clot + d-PTFE Membrane

EXPERIMENTAL

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

Arm 3: Blood Clot + L-PRF

EXPERIMENTAL

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; Procedure: Leukocyte- and Platelet-Rich Fibrin (L-PRF)

Blood Clot + L-PRF + d-PTFE Membrane

EXPERIMENTAL

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)

Interventions

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.

Also known as: Unassisted Socket Healing

Spontaneous 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

Arm 2: Blood Clot + d-PTFE Membrane; Arm 3: Blood Clot + L-PRF

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.

Also known as: L-PRF, Platelet-Rich Fibrin

Arm 3: Blood Clot + L-PRF; Blood Clot + L-PRF + d-PTFE Membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad del Desarrollo: lead

Study Sites (1)

Universidad del Desarrollo (UDD)

Santiago, Santiago Metropolitan, 7610315, Chile

RECRUITING

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Tooth Loss

Interventions

Leukocyte Count

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Francisca c Collao, DDS

  Universidad del Desarrollo

  STUDY DIRECTOR

• Claudio M Miranda, dds

  Universidad del Desarrollo

  PRINCIPAL INVESTIGATOR

• Dusan M Marinkovic, DDS

  Universidad del Desarrollo

  STUDY CHAIR

Central Study Contacts

Claudio M Claudio Miranda, DDS, Director

CONTACT

+56 (2) 2327 9110; clmirandacar@gmail.com

Dusan M Dusan Marinkovic, DDS

CONTACT

+56 (2) 2327 5256; dusan.marinkovic@udd.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors responsible for volumetric, radiographic, and histomorphometric analyses will be blinded to treatment allocation. Due to the nature of the surgical interventions, participants and treating clinicians cannot be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1:1:1 ratio to one of four parallel treatment groups: spontaneous socket healing, autologous blood clot with d-PTFE membrane, autologous blood clot with L-PRF, or autologous blood clot with L-PRF and d-PTFE membrane. Each participant will receive only the assigned intervention and will remain in the same study group throughout the study. Outcomes will be assessed at predefined follow-up intervals up to 24 months after implant loading.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: September 10, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

CL (1)