CompletedNot Applicable

Soft Tissue Volume Changes in Posterior Socket Sealing Abutment.

Spain30 participantsStarted 2022-09-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Soft tissue dimensional changes

Timeframe: From 0 to 6 months

Trial details

NCT IDNCT05722041

SponsorAula Dental Avanzada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

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