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Clinical Trials/NCT05240417
NCT05240417
Recruiting
Not Applicable

Effectiveness of "Pontic-shield" Technique in Alveolar Ridge Preservation: A Randomized Controlled Trial

Universidad Complutense de Madrid1 site in 1 country30 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tooth Extraction Status Nos
Sponsor
Universidad Complutense de Madrid
Enrollment
30
Locations
1
Primary Endpoint
Bone resorption
Status
Recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
December 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jesús Torres García Denche

Associate professor

Universidad Complutense de Madrid

Eligibility Criteria

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

Outcomes

Primary Outcomes

Bone resorption

Time Frame: 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 Outcomes

  • Satisfaction assessed by visual analogue scale (VAS)(From the day of the surgical procedure to the seventh-day)

Study Sites (1)

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