AzTrials
AzTrials

Alveolar Ridge PreservationARPNCT07812883

Volumetric Efficacy of Alveolar Ridge Preservation

A study testing Spontaneous Healing, d-PTFE Membrane and Leukocyte- and Platelet-Rich Fibrin (L-PRF) in people with Alveolar Ridge Preservation and Tooth Loss, run by Universidad del Desarrollo at 1 site in Chile.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Spontaneous Healing, d-PTFE Membrane and Leukocyte- and Platelet-Rich Fibrin (L-PRF)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChile
Study dates
15 Sep 2026to 1 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Chile1 site, 1 recruiting
  • Universidad del Desarrollo (UDD)

    Santiago, Santiago Metropolitan, 7610315

    Claudio m Claudio miranda, dds, +56 (2) 2327 9110, clmirandacar@gmail.com

    Dusan M Marinkovic, DDS, +56 (2) 2327 9110, dusan.marinkovic@udd.cl

    Recruiting

Other trials in Chile

About this study

Official title: 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:

Read more
  • 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.
Read the 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.

Being tested
Spontaneous Healing, d-PTFE Membrane, Leukocyte- and Platelet-Rich Fibrin (L-PRF)
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
Medical subject headings
Tooth Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spontaneous HealingProcedure or surgery

    Also called Unassisted Socket 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.

  • d-PTFE MembraneProcedure or surgery

    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 or surgery

    Also called L-PRF, Platelet-Rich Fibrin

    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.

Study groups in NCT07812883
Study groupRoleWhat they receive
Spontaneous HealingActive comparatorFollowing atraumatic tooth extraction, the socket is left to heal spontaneously without the use of alveolar ridge preservation materials or barrier membranes.
Receives: Procedure: Spontaneous Healing
Arm 2: Blood Clot + d-PTFE MembraneExperimentalFollowing 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.
Receives: Procedure: d-PTFE Membrane
Arm 3: Blood Clot + L-PRFExperimentalFollowing 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.
Receives: Procedure: d-PTFE Membrane; Procedure: Leukocyte- and Platelet-Rich Fibrin (L-PRF)
Blood Clot + L-PRF + d-PTFE MembraneExperimentalFollowing 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.
Receives: Procedure: Leukocyte- and Platelet-Rich Fibrin (L-PRF)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks after tooth extraction

Secondary outcomes (8)
  1. Histomorphometric Bone Formation

    Percentage of newly formed bone, residual biomaterial, and connective tissue/marrow spaces measured in bone biopsy specimens obtained during implant placement.

    Measured: 12 weeks after tooth extraction

  2. Postoperative Pain

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

    Measured: 21 days after tooth extraction

  3. Postoperative Complications

    Frequency and severity of soft-tissue dehiscence, membrane exposure or displacement, localized infection, and uncontrolled acute pain.

    Measured: Up to 12 weeks after tooth extraction

  4. Keratinized Tissue Width

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

    Measured: Baseline to 12 weeks after tooth extraction

  5. Oral Health-Related Quality of Life

    Change in Oral Health Impact Profile (OHIP-14) scores between baseline and definitive implant-supported restoration.

    Measured: Baseline to 24-28 weeks after tooth extraction

  6. Bleeding on probing

    Percentage of peri-implant sites presenting bleeding on probing.

    Measured: 12 and 24 months after implant loading

  7. Peri-implant probing depth

    Mean peri-implant probing depth measured in millimeters using a calibrated periodontal probe.

    Measured: 12 and 24 months after implant loading

  8. Radiographic marginal bone level

    Mean marginal bone level measured radiographically in millimeters around implants.

    Measured: 12 and 24 months after implant loading

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start15 Sep 2026 (estimated)
  3. Primary completion15 Nov 2027 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07812883
Sponsor's protocol ID
2025-115
Other IDs
IDREF Research Grants
Acronym
ARP
Status last verified
Sep 2026
First submitted
7 Jul 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Spontaneous Healing, d-PTFE Membrane and Leukocyte- and Platelet-Rich Fibrin (L-PRF) in people with Alveolar Ridge Preservation and Tooth Loss, run by Universidad del Desarrollo at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claudio M Claudio Miranda, DDS, Director (+56 (2) 2327 9110, clmirandacar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Alveolar Ridge Dimensions (time frame: 12 weeks after tooth extraction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07812883, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in