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OpenTrials
Completed

NCT Number: NCT05722041

Soft Tissue Volume Changes in Posterior Socket Sealing Abutment.

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.

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Key information

Conditions

Dental Implants Immediate Dental Implant Placement Mouth Diseases Periodontal Diseases Soft Tissue Stomatognathic Diseases Tooth Diseases Tooth Loss

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Dental esteve

Alicante, 03001, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate dental implant placement

Procedure

Placement of one dental implant immediately after tooth extraction.

Other names: Dental implant surgery

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Aula Dental Avanzada

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 10, 2023
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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