Soft Tissue Volume Changes in Posterior Socket Sealing Abutment.

Recruiting

• Conditions: Dental Implants
• Interventions: Procedure: Immediate dental implant placement

• Registration Number: NCT05722041
• Lead Sponsor: Aula Dental Avanzada

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-08-11
• Study Start: 2022-09-01
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2024-12-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conventional Abutment	Immediate dental implant placement	Conventional abutment will be placed after molar immediate implant placement.
Customized Abutment	Immediate dental implant placement	Customized abutment will be placed after molar immediate implant placement.

Primary Outcome Measures

Name	Time	Method
Soft tissue dimensional changes	From 0 to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Patients satisfaction	From 0 to 6 months	Patients will be asked about their satisfaction after the treatment in a Numerical Rate Scale form 0 (Not satisfied) to 10 (Very satisfied).

Trial Locations

Locations (1)

Clínica Dental esteve; 🇪🇸 Alicante, Spain