Soft Tissue Volume Changes in Posterior Socket Sealing Abutment.
1 other identifier
interventional
30
1 country
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. Thirty patients in ASA I-II health status who require immediate post-extraction implant treatment in the molar area were recruited after giving their informed consent, and were randomly allocated to two parallel groups (customised abutment vs. conventional abutment). The randomisation list was generated with the List Randomizer tool (Random.org), and allocation was performed by a secretary external to the research team after implant placement. The soft tissue status is recorded before and 6 months after treatment by means of a digital impression taken with the same intraoral scanner. The patient completes a 7-question questionnaire on their perception of the therapeutic process and the final result. A comparative volume measurement is made by digitally superimposing the two mesh files obtained before and 6 months after treatment. Digital models are anonymised and measured by an independent outcome assessor blinded to group allocation. Statistical data are analysed by an external statistician.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedJuly 17, 2026
July 1, 2026
3.3 years
August 11, 2022
July 16, 2026
Conditions
Keywords
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
EXPERIMENTALCustomized abutment will be placed after molar immediate implant placement.
Conventional Abutment
ACTIVE COMPARATORConventional abutment will be placed after molar immediate implant placement.
Interventions
Placement of one dental implant immediately after tooth extraction.
Eligibility Criteria
You may qualify if:
- ASA I or ASA II health status
- Age between 18 and 80 years
- Presence of a molar with poor restorative prognosis requiring extraction and immediate post-extraction implant placement
You may not qualify if:
- Psychiatric conditions or any condition preventing the patient from adequately completing the questionnaire
- Teeth with periodontal involvement and loss of attachment caused by root fracture
- Alveolus with bone deficiencies where an immediate implant cannot be adequately placed
- Medical conditions contraindicating dental implant placement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ClĂnica Dental esteve
Alicante, Alicante, 03001, Spain
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: 22211303RESULTChu 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: 26509983RESULTFinelle 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: 28291855RESULTRuales-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: 31268244RESULTConejo 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: 31582167RESULTAlexopoulou 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: 33438320RESULTLilet 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: 34551159RESULTPerez 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: 31797548RESULTFernandes 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: 34423560RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guillem Esteve-Pardo, PhD
Clinica Dental Esteve
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcome assessor measured anonymized, coded digital models (STL files) and was blinded to group allocation during measurement.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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
July 17, 2026
Record last verified: 2026-07