CompletedNot Applicable

The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement

Italy40 participantsStarted 2021-06-06

Plain-language summary

The present randomized controlled trial aims to assess the influence of a new prosthodontics device (Gingival Former Abutment -GFA) on peri-implant bone loss and soft tissue changes and health after subcrestal oral implant placement. The participants will be divided in two groups and receive either crestal implant placement and traditional healing abutment or subcrestal implant placement and GFA. Clinical and radiographic examination will be performed at implant placement surgery, prosthetic load, 6 and 12 months follow-up.

Who can participate

Age range

18 Years – 75 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: * Ability to comprehend and sign informed consent. * Male and female subjects, aged 18-75 years, inclusive. * Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives). * Good oral health (no decay, periapical or periodontal lesions, PI and BOP \<25%). * Patient with posterior single missing tooth: * for at least 5 months, * mandibular or maxillary, * intercalated (distance between teeth more than 7.5 mm), * at least 11 mm of height residual bone (from bone crest to maxillary sinus or inferior alveolar nerve), * at least 5 mm of bone width (buccal - palatal/lingual). * Availability for the 12-month duration of the study. Exclusion Criteria: * Not willing to follow the agreed protocol. * Presence of orthodontic appliances. * Smokers more than 10 cigarettes per day. * Chronic obstructive pulmonary disease and asthma. * Tumors or significant pathology of the soft or hard tissues of the oral cavity. * Current radiotherapy or chemotherapy. * Pregnant or lactating women. * Parafunctions like bruxism. * Previous interventions to increase bone thickness in the implant area. * Current or past assumption of medications that may influence surgical therapy and/or interfere with healing following surgical treatment. * Systemic diseases that constitute a contraindi…

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 in Marginal Bone Level (MBL)

Timeframe: Surgery, 3, 9 and 15 months

Trial details

NCT IDNCT06182670

SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-07

View on ClinicalTrials.gov More Edentulous Alveolar Ridge trials