NCT06173492

Brief Summary

The loss of a tooth or change in its function is lead to a change in alveolar ridge's height and volume. Socket preservation (SP) is a procedure designed to prevent or limit alteration of the post-extraction bone ridge to achieve an optimal prosthetic implant rehabilitation. The aim of this randomized-controlled clinical trial is to suggest that platelet rich fibrin (PRF) as solely grafting material may be a valid tool in this technique.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

December 7, 2023

Last Update Submit

December 15, 2023

Conditions

Alveolar Bone LossTooth Extraction

Keywords

Dental implantSocket ridge preservationPlatelet Rich Fibrin

Outcome Measures

Primary Outcomes (3)

  • Periodontal probe - alveolar crest distance

    Vertical distance measured with a periodontal probe from the alveolar crest (AC) to a reference periodontal probe (P) connecting the cement-enamel junction (CEJ) of the teeth adjacent.

    Immediately after surgery, 3 months after surgery

  • Width

    Horizontal alveolar ridge thickness from the external face of the buccal wall to the outer face of the lingual side is measured with a hand caliper, 1 mm apically from the alveolar ridge in the central area.

    Immediately after surgery, 3 months after surgery

  • Vestibular bone wall thickness

    It is measured with a hand caliper at the center of the vestibular wall, 1 mm apically from the ridge.

    Immediately after surgery, 3 months after surgery

Secondary Outcomes (1)

  • Wound healing index

    3, 7, 14, 28 days after surgery

Study Arms (2)

Socket ridge preservation with PRF

EXPERIMENTAL

40 ml of blood is drawn and collected in plastic tubes of 10 ml. The tubes are placed in a centrifuge at 2700 rpm for 12 minutes to get the clot of fibrin. After extraction, the clot obtained by centrifugation is made into PRF cylinders and inserted into the socket and compacted.

Procedure: Dental extractionDevice: Platelet Rich Fibrin

Spontaneous healing

ACTIVE COMPARATOR

No treatment is applied. The socket is made to heal spontaneously.

Procedure: Dental extraction

Interventions

Dental extractionPROCEDURE

After local anesthesia (mepivacaine 2%), the tooth is extracted atraumatically with levers and forceps taking care to preserve the cortex. The roots of multi-rooted teeth are separated before extraction. The pocket epithelium and granulation tissue inside the socket are removed.

Socket ridge preservation with PRFSpontaneous healing
Platelet Rich FibrinDEVICE

The clot obtained by centrifugation is made into PRF cylinders and inserted into the socket and compacted.

Socket ridge preservation with PRF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mandibular or maxillary premolars that need to be extracted due to endodontic failure, caries or fractures and will need to be replaced with a dental implant after 3 months of healing
  • Full mouth plaque score ≤ 25% at onset
  • Full mouth bleeding score ≤ 25% at onset
  • Integrity of the alveolar walls after extraction
  • Vestibular wall thickness \< 1 mm
  • Patients able to understand and sign informed consensus

You may not qualify if:

  • Significant medical conditions contraindicating surgery
  • Pregnancy and breastfeeding
  • Tobacco smoking (\>15 cigarettes per day)
  • Immunocompromised patients
  • Alcohol and drug abuse
  • Uncooperative patients
  • Periodontally compromised patients
  • Acute abscesses at the extraction site
  • Other dental elements that are not premolars
  • Patients who do not show up for scheduled checkups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gilberto Sammartino

Naples, 80131, Italy

Location

Related Publications (6)

  • Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.

    PMID: 15691354RESULT

  • Chiapasco M, Zaniboni M, Rimondini L. Dental implants placed in grafted maxillary sinuses: a retrospective analysis of clinical outcome according to the initial clinical situation and a proposal of defect classification. Clin Oral Implants Res. 2008 Apr;19(4):416-28. doi: 10.1111/j.1600-0501.2007.01489.x. Epub 2008 Feb 11.

    PMID: 18266875RESULT

  • Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.

    PMID: 19089687RESULT

  • Cortellini P, Pini Prato G, Baldi C, Clauser C. Guided tissue regeneration with different materials. Int J Periodontics Restorative Dent. 1990;10(2):136-51. No abstract available.

    PMID: 2084057RESULT

  • Zhang Y, Ruan Z, Shen M, Tan L, Huang W, Wang L, Huang Y. Clinical effect of platelet-rich fibrin on the preservation of the alveolar ridge following tooth extraction. Exp Ther Med. 2018 Mar;15(3):2277-2286. doi: 10.3892/etm.2018.5696. Epub 2018 Jan 4.

    PMID: 29456635RESULT

  • Maiorana C, Poli PP, Deflorian M, Testori T, Mandelli F, Nagursky H, Vinci R. Alveolar socket preservation with demineralised bovine bone mineral and a collagen matrix. J Periodontal Implant Sci. 2017 Aug;47(4):194-210. doi: 10.5051/jpis.2017.47.4.194. Epub 2017 Aug 11.

    PMID: 28861284RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Tooth Extraction

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Officials

  • Gilberto Sammartino

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

December 7, 2023

First Posted

December 15, 2023

Study Start

January 11, 2023

Primary Completion

May 10, 2023

Study Completion

November 30, 2024

Last Updated

December 21, 2023

Record last verified: 2023-12

Locations

IT(1)