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RecruitingNCT07812883ARPUpdated Sep 10, 2026

Volumetric Efficacy of Alveolar Ridge Preservation

An interventional study of Spontaneous Healing and d-PTFE Membrane in Alveolar Ridge Preservation, Tooth Loss and Tooth Extraction, sponsored by Universidad del Desarrollo. Recruiting at 1 site in Chile. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Universidad del Desarrollo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
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.

02

Conditions studied

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

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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
03

In context

Tooth Loss

165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.

This study's planned enrollment of 70 is above the median of 30 across 120 interventional studies indexed under Tooth Loss.

Browse Tooth Loss studies →

Lead sponsor

Universidad del Desarrollo is the lead sponsor of 24 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
  • (ASA) Physical Status I or II.
  • Ability to understand the study procedures and provide written .

Exclusion criteria

Exclusion Criteria:

  • Current treatment with bisphosphonates or systemic .
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • 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

  • 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

  • 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 · Procedure: Leukocyte- and 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)

Interventions

  • ProcedureSpontaneous 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.

    Also known as: Unassisted Socket Healing

  • Procedured-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

  • ProcedureLeukocyte- 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.

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

06

What researchers measure

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.

    Time frame: 12 weeks after tooth extraction

Secondary outcomes

  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.

    Time frame: 12 weeks after tooth extraction

  2. Postoperative Pain

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

    Time frame: 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.

    Time frame: Up to 12 weeks after tooth extraction

  4. Keratinized Tissue Width

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

    Time frame: 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.

    Time frame: Baseline to 24-28 weeks after tooth extraction

  6. Bleeding on probing

    Percentage of peri-implant sites presenting bleeding on probing.

    Time frame: 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.

    Time frame: 12 and 24 months after implant loading

  8. Radiographic marginal bone level

    Mean marginal bone level measured radiographically in millimeters around implants.

    Time frame: 12 and 24 months after implant loading

07

Study locations

1 of 1 sites recruiting
  • Universidad del Desarrollo (UDD)
    Santiago, Santiago Metropolitan 7610315, Chile
    Recruiting
    • Claudio m Claudio miranda, dds · Contactclmirandacar@gmail.com · +56 (2) 2327 9110
    • Dusan M Marinkovic, DDS · Contactdusan.marinkovic@udd.cl · +56 (2) 2327 9110
    • Claudio M Miranda, DDS · Principal investigator
    • Francisca c Collao, DDS · Sub investigator
    • Dusan M Marinkovic, DDS · Sub investigator
08

References and documents

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

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07812883
Lead sponsor
Universidad del Desarrollo
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Nov 15, 2027 (estimated)
Completion
Oct 1, 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

Claudio M Claudio Miranda, DDS, Director
Contact
clmirandacar@gmail.com
+56 (2) 2327 9110
Dusan M Dusan Marinkovic, DDS
Contact
dusan.marinkovic@udd.cl
+56 (2) 2327 5256
Francisca c Collao, DDS
study director · Universidad del Desarrollo
Claudio M Miranda, dds
principal investigator · Universidad del Desarrollo
Dusan M Marinkovic, DDS
study chair · Universidad del Desarrollo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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