Soft Tissue Volume Changes in Posterior Socket Sealing Abutment.

Dental Implants Clinical Trial

Official title:

Soft Tissue Volume Changes in the Posterior Area With Socket Sealing Abutment. Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722041
• Other study ID #: CUSTOM
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: Aula Dental Avanzada
• Contact: Guillem Esteve-Pardo, PhD
• Phone: +34965215755
• Email: guillem[@]clinicaesteve.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2025
• Est. primary completion date: December 1, 2024
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Implants

Intervention

Procedure:
• Immediate dental implant placement
Placement of one dental implant immediately after tooth extraction.

Locations

Country	Name	City	State
Spain	Clínica Dental esteve	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Aula Dental Avanzada

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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 — View Citation

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 Tissu — View Citation

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. — View Citation

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. Cli — View Citation

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. — View Citation

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. Epu — View Citation

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 R — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patients satisfaction	Patients will be asked about their satisfaction after the treatment in a Numerical Rate Scale form 0 (Not satisfied) to 10 (Very satisfied).	From 0 to 6 months