CompletedNot Applicable

Impact of Transepithelial Abutment Connection and Disconnection in Dental Implants

Spain32 participantsStarted 2024-11-01

Plain-language summary

Over the past decade, implant research has focused on maintaining the health and stability of peri-implant tissues. A key factor is platform switching at the bone level, where a narrower abutment than the implant is used. This technique increases the implant's horizontal surface area for biological width establishment and reduces stress on the crestal bone. Studies showed that repeated disconnection and reconnection of prosthetic components could compromise the mucosal barrier around implants, leading to an apical shift in the connective tissue junction and vertical tissue loss. This led to the "one abutment, one time" protocol, advocating the placement of the definitive abutment during initial implant surgery to avoid its removal during healing. A recent meta-analysis indicated bone loss at the marginal level due to abutment connection and disconnection, despite different treatment protocols. Thus, a standardized abutment between the fixed prosthesis and the implant has been recommended to preserve marginal bone levels. This approach moves the biological width apically, protecting the bone from irritation and improving marginal bone isolation. However, comparative evidence between direct implant-connected prostheses and trans-epithelial abutments is lacking. This study aims to evaluate the "one abutment, one time" protocol's effect on bone loss 12 months after prosthesis placement. Secondary objectives include assessing patient satisfaction using Patient-Reported Outcome Measures (PROM) during prosthesis fabrication and placement, and obtaining information on the diversity and function of microorganisms on the implant using metagenomic techniques 12 months post-prosthesis placement. Throughout the prosthesis fabrication and the first 12 months, various evaluations will be conducted in both abutment and Ti-base groups: * \*\*Bleeding:\*\* Recorded during various prosthetic stages. * \*\*Pain:\*\* Assessed using a visual analog scale after each stage. * \*\*Anesthesia:\*\* Recorded if used at each stage. * \*\*Radiographs:\*\* Number taken to check the fit. * \*\*Time:\*\* Measured for each prosthetic phase. * \*\*Repetitions:\*\* Number of repeated procedures quantified. * \*\*Metagenomic tests:\*\* Samples collected following the Human Microbiome Project protocol to analyze microbial diversity and function.

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: * Healthy partially edentulous adult patients needing at least two implants for the placement of single or consecutive crowns in the posterior mandible or maxilla will be recruited. * These patients should exhibit a plaque index and gingival bleeding index of less than 25%, and have sufficient bone height and width for the placement of dental implants measuring 8 or 10 mm in length and 3.5 or 4 mm in diameter. * Additionally, they must have at least 2 mm of keratinized vestibular gingiva, stable occlusion, and a periodontium in good health Exclusion Criteria: * Edentulous areas requiring bone grafts will be excluded. * Patients with medical conditions contraindicating implant surgery, such as severe bruxism or inadequate oral hygiene. * Pregnant or lactating women, patients undergoing bisphosphonate therapy, those receiving chemotherapy or radiotherapy in the head and neck area, non-compliant patients with incomplete data records, and those who do not attend regular follow-up appointments will also be excluded.

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

periimplant marginal bone loss

Timeframe: 12 months

Trial details

NCT IDNCT06629961

SponsorUniversity of Valencia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-01

View on ClinicalTrials.gov More Bone Loss trials