Soft Tissue Volume Changes in Posterior Socket Sealing Abutment.

NCT05722041 | Active Not Recruiting

• 1 other identifier: CUSTOM
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to clinically evaluate the effect of the alveolar sealing technique using a customised abutment on soft tissue volume changes following molar extraction and immediate dental implant placement.

Conditions

Dental Implants

Keywords

Dental implant; Immediate implants; Custom Abutment; Sealing Socket Abutment

Outcome Measures

Primary Outcomes (1)

• Soft tissue dimensional changes

  The changes that occur in the soft tissues in millimetres by comparing the digital impressions before and 6 months after the treatment using specific software.

  From 0 to 6 months

Secondary Outcomes (1)

• Patients satisfaction

  From 0 to 6 months

Study Arms (2)

Customized Abutment

Customized abutment will be placed after molar immediate implant placement.

Procedure: Immediate dental implant placement

Conventional Abutment

Conventional abutment will be placed after molar immediate implant placement.

Procedure: Immediate dental implant placement

Interventions

Immediate dental implant placement PROCEDURE

Placement of one dental implant immediately after tooth extraction.

Also known as: Dental implant surgery

Conventional Abutment; Customized Abutment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are assisted in private dental office.

You may qualify if:

• Patients ASA I
• Need for molar postextraction immediate implant

You may not qualify if:

• When the cortical bone is affected and the alveolus presents bone deficiencies
• When dental implant may not be placed due to medical conditions

Sponsors & Collaborators

• Aula Dental Avanzada: lead

Study Sites (1)

Clínica Dental esteve

Alicante, Alicante, 03001, Spain

Location

Related Publications (9)

• Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.

  PMID: 22211303 BACKGROUND

• Chu SJ, Salama MA, Garber DA, Salama H, Sarnachiaro GO, Sarnachiaro E, Gotta SL, Reynolds MA, Saito H, Tarnow DP. Flapless Postextraction Socket Implant Placement, Part 2: The Effects of Bone Grafting and Provisional Restoration on Peri-implant Soft Tissue Height and Thickness- A Retrospective Study. Int J Periodontics Restorative Dent. 2015 Nov-Dec;35(6):803-9. doi: 10.11607/prd.2178.

  PMID: 26509983 BACKGROUND

• Finelle G, Lee SJ. Guided Immediate Implant Placement with Wound Closure by Computer-Aided Design/Computer-Assisted Manufacture Sealing Socket Abutment: Case Report. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):e63-e67. doi: 10.11607/jomi.4770.

  PMID: 28291855 BACKGROUND

• Ruales-Carrera E, Pauletto P, Apaza-Bedoya K, Volpato CAM, Ozcan M, Benfatti CAM. Peri-implant tissue management after immediate implant placement using a customized healing abutment. J Esthet Restor Dent. 2019 Nov;31(6):533-541. doi: 10.1111/jerd.12512. Epub 2019 Jul 3.

  PMID: 31268244 BACKGROUND

• Conejo J, Atria PJ, Hirata R, Blatz MB. Copy milling to duplicate the emergence profile for implant-supported restorations. J Prosthet Dent. 2020 May;123(5):671-674. doi: 10.1016/j.prosdent.2019.05.035. Epub 2019 Oct 1.

  PMID: 31582167 BACKGROUND

• Alexopoulou M, Lambert F, Knafo B, Popelut A, Vandenberghe B, Finelle G. Immediate implant in the posterior region combined with alveolar ridge preservation and sealing socket abutment: A retrospective 3D radiographic analysis. Clin Implant Dent Relat Res. 2021 Feb;23(1):61-72. doi: 10.1111/cid.12974. Epub 2021 Jan 13.

  PMID: 33438320 BACKGROUND

• Lilet R, Desiron M, Finelle G, Lecloux G, Seidel L, Lambert F. Immediate implant placement combining socket seal abutment and peri-implant socket filling: A prospective case series. Clin Oral Implants Res. 2022 Jan;33(1):33-44. doi: 10.1111/clr.13852. Epub 2021 Oct 22.

  PMID: 34551159 BACKGROUND

• Perez A, Caiazzo A, Valente NA, Toti P, Alfonsi F, Barone A. Standard vs customized healing abutments with simultaneous bone grafting for tissue changes around immediate implants. 1-year outcomes from a randomized clinical trial. Clin Implant Dent Relat Res. 2020 Feb;22(1):42-53. doi: 10.1111/cid.12871. Epub 2019 Dec 3.

  PMID: 31797548 BACKGROUND

• Fernandes D, Nunes S, Lopez-Castro G, Marques T, Montero J, Borges T. Effect of customized healing abutments on the peri-implant linear and volumetric tissue changes at maxillary immediate implant sites: A 1-year prospective randomized clinical trial. Clin Implant Dent Relat Res. 2021 Oct;23(5):745-757. doi: 10.1111/cid.13044. Epub 2021 Aug 22.

  PMID: 34423560 BACKGROUND

Study Officials

• Guillem Esteve-Pardo, PhD

  Clinica Dental Esteve

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: February 10, 2023
• Study Start: September 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: February 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

ES (1)