"Pontic-shield" Technique in Alveolar Ridge Preservation

May 14, 2023 updated by: Jesús Torres García Denche, Universidad Complutense de Madrid

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28011
        • Recruiting
        • Luis Miguel Sáez-Alcaide
        • Contact:
          • Luis Miguel Sáez-Alcaide, PhD Student
          • Phone Number: +34665101278
          • Email: lsaez@ucm.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the day of the extraction to 4 months after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction assessed by visual analogue scale (VAS)
Time Frame: 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)
From the day of the surgical procedure to the seventh-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 23, 2022

First Submitted That Met QC Criteria

February 13, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 14, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21/028-EC_X

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bone Loss

Clinical Trials on "Pontic-shield" technique

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe