"Pontic-shield" Technique in Alveolar Ridge Preservation

Sponsor
Universidad Complutense de Madrid (Other)
Overall Status
Recruiting
CT.gov ID
NCT05240417
Collaborator
(none)
30
1
3
23
1.3

Study Details

Study Description

Brief Summary

Alveolar bone resorption after dental extraction frequently leads to situations in which long-term function and esthetic success of rehabilitations with dental implants is a challenge. "Pontic-shield" has been described as an alternative technique to maintain alveolar ridge after tooth extraction.

The aim of this study is to analyze the effectiveness of "Pontic-shield" technique in alveolar ridge preservation comparing to fresh socket and ridge preservation using deproteinized bovine bone and a porcine collagen membrane.

Condition or Disease Intervention/Treatment Phase
  • Procedure: "Pontic-shield" technique
  • Procedure: Alveolar ridge preservation
N/A

Detailed Description

A three-arm randomized clinical study will be conducted:
  • Group 1 (study group): Ridge preservation with "Pontic-shield" technique.

  • Group 2 (positive control): Ridge preservation with deproteinized bovine bone and porcine collagen membrane after tooth extraction.

  • Group 3 (negative control): Tooth extraction only (fresh socket).

A cone-beam computed tomography will be performed prior to tooth extraction and 4 months postoperative. Radiographic changes between before and after intervention will be evaluated to asses the effectiveness of "Pontic-shield" technique.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel three-arm randomized clinical studyParallel three-arm randomized clinical study
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of "Pontic-shield" Technique in Alveolar Ridge Preservation: A Randomized Controlled Trial
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group

"Pontic-shield" will be performed as ridge preservation technique.

Procedure: "Pontic-shield" technique
A 1mm thick fragment of the vestibular aspect of the root will remain after extraction (partial extraction)
Other Names:
  • Partial extraction therapy
  • Active Comparator: Positive control (ridge preservation)

    Deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction.

    Procedure: Alveolar ridge preservation
    Particulate deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction

    No Intervention: Negative control (fresh socket)

    No intervention will be performed after tooth extraction. Blood clot will be maintained after extraction.

    Outcome Measures

    Primary Outcome Measures

    1. Bone resorption [From the day of the extraction to 4 months after]

      Radiographic changes between preoperative (prior to tooth extraction) and postoperative (4 months after intervention) will be analyzed. This variation will be assessed by measuring changes in width and height (in millimeters) of the socket by superimposition of CBCT before and after the intervention.

    Secondary Outcome Measures

    1. Satisfaction assessed by visual analogue scale (VAS) [From the day of the surgical procedure to the seventh-day]

      Postoperative pain with visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patient from 18 to 80 years old

    • Patients who sign the informed consent

    • Need to perform extraction from second premolar to second premolar in maxilla and mandible

    Exclusion Criteria:
    • Tobacco consumption (more than 10 cigarettes per day)

    • Severe systemic disease ( ASA III or IV - American Society of Anaesthesiology)

    • Drug use that could interfere with alveolar bone healing

    • Active periodontal disease

    • Acute or chronic apical pathology of the tooth

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Luis Miguel Sáez-Alcaide Madrid Spain 28011

    Sponsors and Collaborators

    • Universidad Complutense de Madrid

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jesús Torres García Denche, Associate professor, Universidad Complutense de Madrid
    ClinicalTrials.gov Identifier:
    NCT05240417
    Other Study ID Numbers:
    • 21/028-EC_X
    First Posted:
    Feb 15, 2022
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jesús Torres García Denche, Associate professor, Universidad Complutense de Madrid
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 15, 2022