"Pontic-shield" Technique in Alveolar Ridge Preservation

Not Applicable

Recruiting

• Conditions: Tooth Extraction Status Nos; Bone Loss; Bone Resorption
• Interventions: Procedure: Alveolar ridge preservation; Procedure: "Pontic-shield" technique

• Registration Number: NCT05240417
• Lead Sponsor: Universidad Complutense de Madrid

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.

Study Timeline

• Study First Submitted: 2022-01-23
• Study First Submitted QC: 2022-02-13
• Study First Posted: 2022-02-15
• Study Start: 2023-01-01
• Primary Completion: 2023-11-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive control (ridge preservation)	Alveolar ridge preservation	Deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction.
Study group	"Pontic-shield" technique	"Pontic-shield" will be performed as ridge preservation technique.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Luis Miguel Sáez-Alcaide; 🇪🇸 Madrid, Spain