Control GroupTest group - Implant restoration with a temporary crown
Control Group: Placement of a Lynx CONNECT dental implant following the standard surgical protocol.
Attachment of a healing abutment (\~1 mm above the soft tissue) instead of immediate restoration.
Healing abutment remains in place for 3 months until final impression is taken for definitive crown fabrication.
Post-operative care: antibiotics (amoxicillin 1.5 g/day or clindamycin 900 mg/day for 3 days), chlorhexidine rinse 0.2%, ibuprofen up to 1.2 g/day.
Follow-up visits at 10-14 days, 3 months, 6 months, and 12 months for clinical and radiographic assessment.
Test group - Implant restoration with a temporary crown: Placement of a Lynx CONNECT dental implant following the standard surgical protocol.
Immediate attachment of a temporary screw-retained crown on the implant abutment (CONNECT).
Occlusion adjusted to avoid full contact with antagonist teeth. Temporary crown will remain for 3 months until final impression is taken for definitive crown fabrication.
Post-operative care: antibiotics (amoxicillin 1.5 g/day or clindamycin 900 mg/day for 3 days), chlorhexidine rinse 0.2%, ibuprofen up to 1.2 g/day.
Follow-up visits at 10-14 days, 3 months, 6 months, and 12 months for clinical and radiographic assessment.
Study summary
The main objective of this scientific study is to evaluate the short-term (1-year) survival and success rates of dental implants restored immediately compared to implants restored after a three-month healing period.
The total duration of the study is 12 months following implant placement, during which clinical and radiographic evaluations will be carried out at different follow-up time points.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* Men and women between 18 and 70 years of age.
* Ability to read, understand, and sign the informed consent form.
* Need for placement of one or more implants for fixed prosthetic rehabilitation in either arch.
* Insertion torque ≥ 35 Ncm (lower values will be excluded from the study).
* Adequate bone dimensions to receive an implant with diameter ≥ 3.75 mm and length ≥ 10 mm.
* Bone type I to III at the insertion site.
* Good oral hygiene: FMBS and FMPS ≤ 25%.
* Systemic status classified as ASA I or II.
Exclusion Criteria:
* Inability to attend follow-up appointments.
* Systemic contraindications to oral surgery (ASA III or IV).
* Pregnancy or breastfeeding.
* Chronic use of corticosteroids, bisphosphonates, or RANKL inhibitors within the last year.
* Alcohol or drug abuse.
* Heavy smoking (≥ 10 cigarettes/day).
* Previous radiotherapy in the cervicofacial region.
* Untreated active periodontal disease.
* Absence of antagonist teeth.
* Local pathology at the planned implant site.
* Uncontrolled diabetes mellitus (HbA1c \> 7%).
* Bone type IV at the surgical site.
Primary outcome measure(s)
Implant survival rate — - Immediately after placement (Visit 1) - confirm placement - 10-14 days post-op (Visit 2) - 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6) Any implant removed after placement will be considered a failure, whatever the reason. Implant survival will be evaluated clinically and radiographically by counting the remaining implants. The implant survival rate will be calculated by dividing the number of non-failures by the number of installed implants. In addition, the implant survival rate will be calculated at the patient level and on an implant level.
Trial sites (1)
Facility
City
Region
Status
Faculdade De Medicina Dentaria da Universidade do Porto
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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