"Pontic-shield" Technique in Alveolar Ridge Preservation

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05240417
• Other study ID #: 21/028-EC_X
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2023
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Loss
• Bone Resorption
• Tooth Extraction Status Nos

Intervention

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

Locations

Country	Name	City	State
Spain	Luis Miguel Sáez-Alcaide	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. Erratum In: J Clin Periodontol. 2020 Jan;47(1):129. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone resorption	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.	From the day of the extraction to 4 months after
Secondary	Satisfaction assessed by visual analogue scale (VAS)	Postoperative pain with visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain)	From the day of the surgical procedure to the seventh-day