| NCT ID | NCT05663385 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Dental Implant |
| Study Type | OBSERVATIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-04-16 |
| Primary Completion | 2025-08-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 75 participants in total. It began in 2024-04-16 with a primary completion date of 2025-08-14.
⚠ 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
Rationale: Early implant placement with alveolar ridge preservation (ARP) using either a collagen matrix or a palatal graft rendered similar esthetic, clinical and PROMs to early implant placement without ARP, up to 1 year after functional loading. Objective: The aim of this study is to evaluate esthetic and clinical outcomes and patient satisfaction following single-tooth replacement in the anterior maxilla in patients treated with a xenograft and a collagen matrix or a free connective tissue graft versus spontaneous healing 5 years after loading Study design: prospective observational study with 5-year follow-up Intervention (if applicable): not applicable Main study parameters/endpoints: Comparison of the level of the buccal marginal gingiva (midfacial mucosa level) between ARP versus spontaneous healing Secondary parameters/endpoint: Peri-implant esthetic score (PES) and white esthetic score (WES), complications, implant survival; and success, Plaque Index, Modified bleeding index, Gingival Index, Probing Depth, PROMs, bone and soft tissue volumetric dimensional changes.
Eligibility Criteria
Inclusion Criteria: * All patients previously included in the above mentioned RCT. Exclusion Criteria: * Patients treated with radiotherapy during follow-up in the head-and-neck region or current chemotherapy; disability (mental and/or physical) to maintain basic oral hygiene procedures.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05663385 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dental Implant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05663385 currently recruiting?
Yes, NCT05663385 is actively recruiting participants. Contact the research team at j.pijpe@erasmusmc.nl for enrollment information.
Where is the NCT05663385 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT05663385 clinical trial?
NCT05663385 is sponsored by Erasmus Medical Center. The trial plans to enroll 75 participants.