Volumetric Efficacy of Alveolar Ridge Preservation (ARP)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Claudio M Claudio Miranda, DDS, Director
- Telefonnummer: +56 (2) 2327 9110
- E-Mail: clmirandacar@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Dusan M Dusan Marinkovic, DDS
- Telefonnummer: +56 (2) 2327 5256
- E-Mail: dusan.marinkovic@udd.cl
Studienorte
-
-
Santiago Metropolitan
-
Santiago, Santiago Metropolitan, Chile, 7610315
- Rekrutierung
- Universidad del Desarrollo (UDD)
-
Kontakt:
- Claudio m Claudio miranda, dds
- Telefonnummer: +56 (2) 2327 9110
- E-Mail: clmirandacar@gmail.com
-
Kontakt:
- Dusan M Marinkovic, DDS
- Telefonnummer: +56 (2) 2327 9110
- E-Mail: dusan.marinkovic@udd.cl
-
Hauptermittler:
- Claudio M Miranda, DDS
-
Unterermittler:
- Francisca c Collao, DDS
-
Unterermittler:
- Dusan M Marinkovic, DDS
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Spontaneous Healing
Following atraumatic tooth extraction, the socket is left to heal spontaneously without the use of alveolar ridge preservation materials or barrier membranes.
|
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.
Andere Namen:
|
|
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.
|
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.
|
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
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.
Andere Namen:
|
|
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.
|
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.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Alveolar Ridge Dimensions
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Histomorphometric Bone Formation
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 12 and 24 months after implant loading
|
Mean marginal bone level measured radiographically in millimeters around implants.
|
12 and 24 months after implant loading
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Francisca c Collao, DDS, Universidad del Desarrollo
- Hauptermittler: Claudio M Miranda, dds, Universidad del Desarrollo
- Studienstuhl: Dusan M Marinkovic, DDS, Universidad del Desarrollo
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Parodontale Erkrankungen
- Mundkrankheiten
- Stomatognathe Erkrankungen
- Zahnerkrankungen
- Zahnverlust
- Untersuchungstechniken
- Klinische Labortechniken
- Diagnosetechniken und Verfahren
- Diagnose
- Zellzahl
- Zytologische Techniken
- Hämatologische Tests
- Zellphysiologische Phänomene
- Blut physiologische Phänomene
- Kreisende und respiratorische physiologische Phänomene
- Blutkörperchenzahl
- Leukozytenzahl
Andere Studien-ID-Nummern
- 2025-115
- IDREF Research Grants (Andere Zuschuss-/Finanzierungsnummer: International Congress of Oral Implantologists)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .