Health TrialsbyHealthPanel

Immediate Restoration of a New Implant With High Primary Stability

ConditionsDental ImplantsImmediate Dental Implant Loading
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversidade do Porto

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Control Group

    Device

    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

    Device

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Test group - Implant restoration with a temporary crownExperimental treatment 1 intervention
Group B: Control Group - Healing abutment on implantActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Implant survival rate

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.

Time frame
- 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)

Secondary outcomes

1

Implant success rate

Defined as probing depth (PD) \< 6 mm together with the absence of bleeding or suppuration on probing and a radiographic marginal bone level (MBL) \< 1.5 mm.

Time frame
- Immediately post-insertion (Visit 1) - 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)
2

Prosthetic success

Defined as the presence of the definitive prosthesis with patient satisfaction and without complications, including and not limited to fracture/chipping, screw loosening, and prosthesis mobility.

Time frame
- 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)
3

Implant insertion torque

Using a motor device or a torque-controlled hand rachet

Time frame
Immediately at implant placement (Visit 1)
4

Marginal bone changes

Measured on parallel intra-oral radiographs using computer software. Marginal bone level alterations will be determined from radiographs and expressed as the distance from the implant reference point (shoulder) to the most coronal bone-to-implant contact on the mesial and distal side of the implant.

Time frame
- 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade do Porto

Lead sponsor

MIS Implants Technologies Ltd

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: