Soft Tissue Volume Changes in Posterior Socket Sealing Abutment.

NCT ID: NCT05722041

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2026-02-01

Brief Summary

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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.

Detailed Description

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A sample of 20 patients in ASAI health status who agree to be involved in the study after giving their consent and who require immediate post-extraction implant treatment in the molar area will be recruited.

The soft tissue status before and 6 months after tooth extraction will be recorded by means of a digital impression taken with the same intraoral scanner.

The patient will be asked to complete a 7-question questionnaire to inform us about his or her perception of the therapeutic process and the final result.

A comparative volume measurement will be made by digitally superimposing the two mesh files obtained before and 6 months after the treatment.

Statistical data will be analysed by an external statistician and conclusions will be drawn about the effect of the technique on soft tissue volume as well as the patient's perception of the procedure and its outcome.

Conditions

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Dental Implants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Customized Abutment

Customized abutment will be placed after molar immediate implant placement.

Immediate dental implant placement

Intervention Type PROCEDURE

Placement of one dental implant immediately after tooth extraction.

Conventional Abutment

Conventional abutment will be placed after molar immediate implant placement.

Immediate dental implant placement

Intervention Type PROCEDURE

Placement of one dental implant immediately after tooth extraction.

Interventions

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Immediate dental implant placement

Placement of one dental implant immediately after tooth extraction.

Intervention Type PROCEDURE

Other Intervention Names

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Dental implant surgery

Eligibility Criteria

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Inclusion Criteria

* Patients ASA I
* Need for molar postextraction immediate implant

Exclusion Criteria

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

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aula Dental Avanzada

OTHER

Sponsor Role lead

Responsible Party

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Guillem Esteve-Pardo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillem Esteve-Pardo, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinica Dental Esteve

Locations

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ClĂ­nica Dental esteve

Alicante, Alicante, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 22211303 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26509983 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28291855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31268244 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31582167 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33438320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34551159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31797548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34423560 (View on PubMed)

Other Identifiers

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CUSTOM

Identifier Type: -

Identifier Source: org_study_id

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