NCT06629961 Impact of Transepithelial Abutment Connection and Disconnection in Dental Implants
| NCT ID | NCT06629961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Valencia |
| Condition | Bone Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2024-11-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06629961 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bone Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06629961 currently recruiting?
Yes, NCT06629961 is actively recruiting participants. Contact the research team at david.penarrocha@uv.es for enrollment information.
Where is the NCT06629961 trial being conducted?
This trial is being conducted at Valencia, Spain, Valencia, Spain.
Who is sponsoring the NCT06629961 clinical trial?
NCT06629961 is sponsored by University of Valencia. The trial plans to enroll 32 participants.