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Recruiting NCT05240417

"Pontic-shield" Technique in Alveolar Ridge Preservation

No phase Interventional Tooth Extraction Status Nos Bone Loss Bone Resorption

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: "Pontic-shield" technique, Alveolar ridge preservation.
Who it may be relevant to
Registry conditions: Tooth Extraction Status Nos, Bone Loss, Bone Resorption. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure "Pontic-shield" technique
    A 1mm thick fragment of the vestibular aspect of the root will remain after extraction (partial extraction)
  • Procedure Alveolar ridge preservation
    Particulate deproteinized bovine bone and porcine collagen membrane will be placed after tooth extraction

Primary outcome measures

  • Bone resorption [Time frame: From the day of the extraction to 4 months after]
Secondary outcome measures (1)
  • Satisfaction assessed by visual analogue scale (VAS) [Time frame: From the day of the surgical procedure to the seventh-day]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Luis Miguel Sáez-Alcaide — Madrid

Publications

  • 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. PMID 30623987
  • 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. PMID 34826029
  • 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. PMID 34087383
  • 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. PMID 20712701
  • 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. PMID 15691354

Identifiers

NCT: NCT05240417 · 21/028-EC_X

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗