RecruitingNot Applicable

Effect of Abutment Configuration on Peri-implant Soft and Hard Tissue in the Esthetic Zone - Randomized Clinical Trial

Hungary30 participantsStarted 2023-12-13

Plain-language summary

The aims of our study are to investigate in patients with immediate implantation replacing a single tooth in the maxillary anterior (#FDI 15-25) region the effect of (a) custom vs cylindrical stock healing abutments, then (b) screw retained single ceramic crowns, on the peri implant hard- and soft-tissue formation and blood flow.

Who can participate

Age range

18 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: * patients over 18 years * good general health * good oral hygiene (FMPS \< 25%) * healthy periodontium (PPD \< 4mm) * thick phenotype * maxilla anterior region (extended to 15-25 positions) * solo missing teeth, intact adjacent teeth * type 1 alveolar shape after extraction 1 * retained occlusion * baseline buccal bone wall thickness at least 1.5 mm, based on intact CBCT scan * patient voluntarily accepts and signs the information and consent form for the study Exclusion Criteria: * general ill health * general surgical or oral surgery contraindication * a patient who has undergone local radiotherapy * active periodontal inflammation, inflammation of the alveolar cavity * smoking * posterior region * pregnancy, lactation * psychological or mental involvement affecting individual plaque control * presence of an implant adjacent to the planned implant * inadequate oral hygiene * need for vertical bone augmentation * gingival recession * Inappropriate implant position for screw fixation * bruxism

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

midfacial keratinized mucosa volume

Timeframe: 4, 12, 36 months post op.

midfacial keratinized mucosa width

Timeframe: 4, 12, 36 months post op.

Keratinized mucosa thickness

Timeframe: before implantation, 4,12, 36 months post op.

Trial details

NCT IDNCT06407271

SponsorSemmelweis University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-30

Contact for this trial

Krisztina Mikulás, PhD

+36309365144 mikulas.krisztina1@semmelweis.hu

View on ClinicalTrials.gov More Dental Implants, Single-Tooth trials