UnknownNot Applicable

Evaluation of MBL Around Implants Placed in Crestal or Subcrestal Positions: a RCT

China20 participantsStarted 2019-04-17

Plain-language summary

The objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the IAI at different positions in relation to the alveolar crest

Who can participate

Age range

18 Years – 70 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

. Absence of 2-4 teeth in the posterior region of the maxilla or mandibular;
. Bone volume sufficient for implants with 4.1-mm size and 8- to 12-mm height and with no need for hard or soft tissue augmentation for implant treatment;
. Periodontally healthy.

Exclusion criteria

. Systemic diseases that may affect bone and soft tissue healing, such as diabetes, osteoporosis, Paget's disease, and patients with cancer;
. Uncontrolled periodontal disease or poor oral health with neither good nor adequate plaque control;
. Parafunctional habits, such as the grinding or clenching of teeth;
. Smoking habit (more than 10 cigarettes per day);
. Pregnancy and breastfeeding.

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

Marginal bone loss(MBL)

Timeframe: Change from baseline up to 5 years after implantation

Trial details

NCT IDNCT03806608

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

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