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NCT Number: NCT05240417

"Pontic-shield" Technique in Alveolar Ridge Preservation

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.

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Key information

Conditions

Tooth Extraction Status Nos Bone Diseases Bone Diseases, Metabolic Bone Loss Bone Resorption Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luis Miguel Sáez-Alcaide

Madrid, 28011, Spain

Location status: Recruiting

Location contact

Luis Miguel Sáez-Alcaide, PhD Student

CONTACT

[email protected]

+34665101278

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Pontic-shield" technique

Procedure

A 1mm thick fragment of the vestibular aspect of the root will remain after extraction (partial extraction)

Other names: Partial extraction therapy

Alveolar ridge preservation

Procedure

Particulate deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction

Primary outcomes

  1. 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

  1. 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)

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 15, 2022
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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