Soft Tissue Volume Changes in Posterior Socket Sealing Abutment.

July 16, 2026 updated by: Guillem Esteve-Pardo, Aula Dental Avanzada

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirty patients in ASA I-II health status requiring immediate post-extraction implant treatment in the molar area were recruited after informed consent and randomly allocated to two parallel groups: an experimental group receiving a customised sealing abutment and a control group receiving a conventional abutment, both after immediate implant placement.

The randomisation list was generated with the List Randomizer tool (Random.org), and group allocation was performed by a secretary external to the research team after implant placement, ensuring allocation concealment.

Soft tissue status is recorded before and 6 months after treatment using a digital impression taken with the same intraoral scanner (Medit i700). Patients complete a 7-question questionnaire on their perception of the therapeutic process and outcome.

Volumetric change is measured by digitally superimposing the mesh files obtained before and 6 months after treatment. Digital models are anonymised and coded, and measured by an independent outcome assessor blinded to group allocation. Statistical analysis is performed by an external statistician.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Alicante, Alicante, Spain, 03001
        • Clínica Dental esteve

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Patients who are assisted in private dental office.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Customized Abutment
Customized abutment will be placed after molar immediate implant placement.
Procedure: Immediate dental implant placement
Placement of one dental implant immediately after tooth extraction.
Other Names:
  • Dental implant surgery
Active Comparator: Conventional Abutment
Conventional abutment will be placed after molar immediate implant placement.
Procedure: Immediate dental implant placement
Placement of one dental implant immediately after tooth extraction.
Other Names:
  • Dental implant surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue dimensional changes
Time Frame: 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.
From 0 to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients satisfaction
Time Frame: 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).
From 0 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aula Dental Avanzada

Investigators

  • Principal Investigator: Guillem Esteve-Pardo, PhD, Clínica Dental esteve

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

February 1, 2026

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUSTOM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data sets obtained during the course of this study will be made available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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