"Pontic-shield" Technique in Alveolar Ridge Preservation

NCT ID: NCT05240417

Last Updated: 2024-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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.

Conditions

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Tooth Extraction Status Nos Bone Loss Bone Resorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel three-arm randomized clinical study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Study group

"Pontic-shield" will be performed as ridge preservation technique.

Group Type EXPERIMENTAL

"Pontic-shield" technique

Intervention Type PROCEDURE

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

Positive control (ridge preservation)

Deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction.

Group Type ACTIVE_COMPARATOR

Alveolar ridge preservation

Intervention Type PROCEDURE

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

Negative control (fresh socket)

No intervention will be performed after tooth extraction. Blood clot will be maintained after extraction.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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"Pontic-shield" technique

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

Intervention Type PROCEDURE

Alveolar ridge preservation

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

Intervention Type PROCEDURE

Other Intervention Names

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Partial extraction therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Jesús Torres García Denche

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Luis Miguel Sáez-Alcaide

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Luis Miguel Sáez-Alcaide, PhD Student

Role: primary

+34665101278

References

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Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.

Reference Type BACKGROUND
PMID: 30623987 (View on PubMed)

Canullo L, Del Fabbro M, Khijmatgar S, Panda S, Ravida A, Tommasato G, Sculean A, Pesce P. Dimensional and histomorphometric evaluation of biomaterials used for alveolar ridge preservation: a systematic review and network meta-analysis. Clin Oral Investig. 2022 Jan;26(1):141-158. doi: 10.1007/s00784-021-04248-1. Epub 2021 Nov 26.

Reference Type BACKGROUND
PMID: 34826029 (View on PubMed)

Saez-Alcaide LM, Gonzalez Fernandez-Tresguerres F, Cortes-Breton Brinkmann J, Segura-Mori L, Iglesias-Velazquez O, Perez-Gonzalez F, Lopez-Pintor RM, Torres Garcia-Denche J. Socket shield technique: A systematic review of human studies. Ann Anat. 2021 Nov;238:151779. doi: 10.1016/j.aanat.2021.151779. Epub 2021 Jun 1.

Reference Type BACKGROUND
PMID: 34087383 (View on PubMed)

Hurzeler MB, Zuhr O, Schupbach P, Rebele SF, Emmanouilidis N, Fickl S. The socket-shield technique: a proof-of-principle report. J Clin Periodontol. 2010 Sep;37(9):855-62. doi: 10.1111/j.1600-051X.2010.01595.x.

Reference Type BACKGROUND
PMID: 20712701 (View on PubMed)

Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.

Reference Type BACKGROUND
PMID: 15691354 (View on PubMed)

Other Identifiers

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21/028-EC_X

Identifier Type: -

Identifier Source: org_study_id

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