Soft Tissue Volume Changes in Posterior Socket Sealing Abutment.

Sponsor
Aula Dental Avanzada (Other)
Overall Status
Recruiting
CT.gov ID
NCT05722041
Collaborator
(none)
20
1
27
0.7

Study Details

Study Description

Brief Summary

The aim is to clinically evaluate the effect of the alveolar sealing technique using a customised abutment on soft tissue volume changes following molar extraction and immediate dental implant placement.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Immediate dental implant placement

Detailed Description

A sample of 20 patients in ASAI health status who agree to be involved in the study after giving their consent and who require immediate post-extraction implant treatment in the molar area will be recruited.

The soft tissue status before and 6 months after tooth extraction will be recorded by means of a digital impression taken with the same intraoral scanner.

The patient will be asked to complete a 7-question questionnaire to inform us about his or her perception of the therapeutic process and the final result.

A comparative volume measurement will be made by digitally superimposing the two mesh files obtained before and 6 months after the treatment.

Statistical data will be analysed by an external statistician and conclusions will be drawn about the effect of the technique on soft tissue volume as well as the patient's perception of the procedure and its outcome.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Soft Tissue Volume Changes in the Posterior Area With Socket Sealing Abutment. Randomized Controlled Trial.
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Customized Abutment

Customized abutment will be placed after molar immediate implant placement.

Procedure: Immediate dental implant placement
Placement of one dental implant immediately after tooth extraction.
Other Names:
  • Dental implant surgery
  • Conventional Abutment

    Conventional abutment will be placed after molar immediate implant placement.

    Procedure: Immediate dental implant placement
    Placement of one dental implant immediately after tooth extraction.
    Other Names:
  • Dental implant surgery
  • Outcome Measures

    Primary Outcome Measures

    1. Soft tissue dimensional changes [From 0 to 6 months]

      The changes that occur in the soft tissues in millimetres by comparing the digital impressions before and 6 months after the treatment using specific software.

    Secondary Outcome Measures

    1. Patients satisfaction [From 0 to 6 months]

      Patients will be asked about their satisfaction after the treatment in a Numerical Rate Scale form 0 (Not satisfied) to 10 (Very satisfied).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Patients ASA I

    • Need for molar postextraction immediate implant

    Exclusion Criteria:
    • When the cortical bone is affected and the alveolus presents bone deficiencies

    • When dental implant may not be placed due to medical conditions

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ClĂ­nica Dental esteve Alicante Spain 03001

    Sponsors and Collaborators

    • Aula Dental Avanzada

    Investigators

    • Principal Investigator: Guillem Esteve-Pardo, PhD, Clinica Dental Esteve

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guillem Esteve-Pardo, Principal Investigator, Aula Dental Avanzada
    ClinicalTrials.gov Identifier:
    NCT05722041
    Other Study ID Numbers:
    • CUSTOM
    First Posted:
    Feb 10, 2023
    Last Update Posted:
    Feb 10, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guillem Esteve-Pardo, Principal Investigator, Aula Dental Avanzada

    Study Results

    No Results Posted as of Feb 10, 2023