Immediate Restoration of a New Implant With High Primary Stability
CT
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2026
CompletedFirst Posted
Study publicly available on registry
March 27, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2027
Study Completion
Last participant's last visit for all outcomes
December 30, 2027
May 5, 2026
February 1, 2026
1.5 years
March 19, 2026
April 28, 2026
Conditions
Keywords
Outcome Measures
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.
- 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 (10)
Implant success rate
- 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)
Prosthetic success
- 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)
Implant insertion torque
Immediately at implant placement (Visit 1)
Marginal bone changes
- 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)
A pink esthetic score/white esthetic score (PES/WES)
- 12 months ±2 weeks (Visit 6)
- +5 more secondary outcomes
Study Arms (2)
Test group - Implant restoration with a temporary crown
EXPERIMENTALImmediately after surgery, the implants of the test group will receive temporary restoration with a screw-retained pre-prepared temporary crown. It will be bound to a temporary titanium temporary abutment for CONNECT. Occlusion will be checked to avoid complete occlusal contact with the antagonist teeth in static and dynamic relationships. Afterward, it will be finished, polished, and screwed to the Connect (hand screwdriver).
Control Group - Healing abutment on implant
ACTIVE COMPARATORA healing abutment of no more than one mm above the soft tissue will be attached to the Connect with a hand screwdriver.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade do Portolead
- MIS Implants Technologies Ltdcollaborator
Study Sites (1)
Faculdade De Medicina Dentaria da Universidade do Porto
Porto, 4200-393, Portugal
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2026
First Posted
March 27, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
December 30, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
May 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 12 months following publication of the primary results and ending 36 months after publication.
- Access Criteria
- Access to de-identified individual participant data will be granted to qualified researchers upon reasonable request. Requests should include a research proposal and statistical analysis plan. Data will be shared following review and approval by the study investigators and after signing a data sharing agreement.
De-identified individual participant data (IPD) collected during the study, including demographic characteristics, baseline clinical data, intervention details, primary and secondary outcome measures, and adverse events data. Data dictionaries describing the variables will also be made available.