"Pontic-shield" Technique in Alveolar Ridge Preservation

NCT05240417 | Recruiting DMC

• 1 other identifier: 21/028-EC_X
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Extraction Status Nos; Bone Loss; Bone Resorption

Keywords

Tooth extraction; Alveolar ridge preservation; Partial extraction therapies; Bone resorption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Satisfaction assessed by visual analogue scale (VAS)

  From the day of the surgical procedure to the seventh-day

Study Arms (3)

Study group

EXPERIMENTAL

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

Procedure: "Pontic-shield" technique

Positive control (ridge preservation)

ACTIVE COMPARATOR

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

Procedure: Alveolar ridge preservation

Negative control (fresh socket)

NO INTERVENTION

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

Interventions

"Pontic-shield" technique PROCEDURE

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

Also known as: Partial extraction therapy

Study group

Alveolar ridge preservation PROCEDURE

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

Positive control (ridge preservation)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Luis Miguel Sáez-Alcaide

Madrid, 28011, Spain

RECRUITING

Related Publications (5)

• 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. doi: 10.1111/jcpe.13212.

  PMID: 30623987 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic; Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Parallel three-arm randomized clinical study

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: February 15, 2022
• Study Start: January 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)