CompletedNot Applicable

Patient-reported Outcome Measures Comparing Static Computer-aided Implant Surgery and Conventional Implant Surgery

Thailand40 participantsStarted 2019-07-09

Plain-language summary

The aim of this randomized controlled trial was to compare PROMs in patients receiving single tooth replacement in posterior sites by s-CAIS and CIS.

Who can participate

Age range

25 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: * Healthy or well-controlled systemic disease (ASA classification I,II) * A partially edentulous ridge in the premolar-molar region with existing two-sided interproximal as well as antagonist contacts * No sign of acute oral infection * Periodontally healthy (or successfully treated) * More than 2 mm of keratinized gingiva at the site of surgery * Sufficient bony ridge for implant placement with or without simultaneous bone grafting Exclusion Criteria: * Diabetes mellitus * Smoking more than ten cigarettes per day * Pregnancy * Psychiatric disorder * History of radiation therapy at head and neck area and chemotherapy * Bony pathologies, namely osseous dysplasia, odontogenic cyst, tumor * History of soft tissue grafting at the prospective implant site * Inadequate bony ridge with the need of bone augmentation prior to 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

Change of post-operative pain for 7 days: Visual Analog Scale

Timeframe: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.

Change of the proportion of time spent in severe pain for 7 days: 5-category Likert scale

Timeframe: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.

Change of the analgesics taken per day for 7 days: the number of tablets per day

Timeframe: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.

Change of Oral Health-Related Quality of Life (OHRQoL) for 7 days: 5-category Likert scale

Timeframe: Patients were instructed to answer the OHRQoL every day for 7 days starting from the day of surgery 1 hour before bedtime.

Trial details

NCT IDNCT04950491

SponsorMahidol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-27

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