Clinical trial NCT05240417: "Pontic-shield" Technique in Alveolar Ridge Preservation
Official title: Effectiveness of "Pontic-shield" Technique in Alveolar Ridge Preservation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tooth Extraction Status Nos
Bone Loss
Bone Resorption
Keywords: Tooth extraction
Alveolar ridge preservation
Partial extraction therapies
Bone resorption
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel three-arm randomized clinical study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bone resorption
timeFrame: From the day of the extraction to 4 months after
Secondary outcomes:
measure: Satisfaction assessed by visual analogue scale (VAS)
timeFrame: From the day of the surgical procedure to the seventh-day
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Luis Miguel Sáez-Alcaide
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.