AzTrials
AzTrials

Dental ImplantsCTNCT07498556

Immediate Restoration of a New Implant With High Primary Stability

A study testing Test group - Implant restoration with a temporary crown in people with Dental Implants and Immediate Dental Implant Loading, run by Universidade do Porto at 1 site in Portugal.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Test group - Implant restoration with a temporary crown
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 sitePortugal
Study dates
1 Jul 2026to 30 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ricardo Faria Almeida, Full Professor contact

+351220901100

ralmeida@fmd.up.pt

Portugal1 site
  • Faculdade De Medicina Dentaria da Universidade do Porto

    Porto, 4200-393

    Ricardo Faria Almeida, Full Professor, +351220901100

    Francisco Correia, +351220901100, fcorreia@fmd.up.pt

Other trials in Portugal

About this study

Official title: Immediate Restoration of a New Implant With High Primary Stability: A 1-year Follow-up - Clinical Study

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.

Read the detailed description

The present study aims to prospectively and in a controlled manner evaluate the short-term (1-year) survival and success rates of immediately restored dental implants compared with implants restored after a three-month healing period.

The study will be conducted at the Faculty of Dental Medicine of the University of Porto, under the coordination of Professor Ricardo Faria de Almeida, in collaboration with MIS Implants Technologies Ltd.

Working Hypothesis The null hypothesis of the present study states that both clinical groups will present similar implant survival rates at the end of one year of follow-up.

Materials and Methods Study Design The present study was designed as a non-interventional, prospective, randomized, controlled clinical study with two parallel groups, intended to compare the clinical and radiographic performance of implants rehabilitated with immediate loading versus implants rehabilitated after a three-month healing period.

Outcome Variables

Primary objective:

Implant survival rate at 12 months.

Secondary objectives:

Implant success rate at 12 months. Prosthetic success rate at 12 months. Marginal bone level changes at 6 and 12 months after implant placement, assessed on standardized intraoral radiographs.

Implant insertion torque. Esthetic evaluation according to the Pink Esthetic Score (PES) and White Esthetic Score (WES).

Sample Size The study will include 50 patients.

Target Population Partially edentulous patients who are candidates for rehabilitation with osseointegrated implants in either arch, anterior or posterior to the canine region, will be included.

Study Devices MIS LYNX implants (MIS Implants Technologies, Israel), supplied with single-use drills.

CONNECT abutments. Healing abutments and provisional abutments for CONNECT. Screw-retained provisional crowns. M-GUIDE surgical guide system (used when clinically necessary).

Study Duration Each participant will be followed for a period of 12 months after implant placement.

The study is expected to be completed by December 30, 2027.

Inclusion and Exclusion Criteria 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.

Ethical Considerations This study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.

Being tested
Control Group, Test group - Implant restoration with a temporary crown
Keywords
dental implants, Immediate loading, Delayed loading, Implant survival rate, Marginal bone loss, Esthetic outcome evaluation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control GroupDevice

    Also called Healing abutment on implant

    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 crownDevice

    Also called 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 groups in NCT07498556
Study groupRoleWhat they receive
Test group - Implant restoration with a temporary crownExperimentalImmediately 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).
Receives: Device: Test group - Implant restoration with a temporary crown
Control Group - Healing abutment on implantActive comparatorA healing abutment of no more than one mm above the soft tissue will be attached to the Connect with a hand screwdriver.
Receives: Device: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: - 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)
  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.

    Measured: - 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.

    Measured: - 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

    Measured: 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.

    Measured: - 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)

  5. A pink esthetic score/white esthetic score (PES/WES)

    At 1 year after the definitive prosthesis placement by an independent examiner by following the Belser's classification.

    The score can range between 0 and 10 for both PES and WES.

    Measured: - 12 months ±2 weeks (Visit 6)

  6. 7.1 Clinical measurements - Gingival index

    Gingival index - Silness and Loe. Using a plastic probe

    Scale:

    0: Normal gingiva. No inflammation, no bleeding.

    1. Mild inflammation. Slight change in color, slight edema, but no bleeding on probing.
    2. Moderate inflammation. Redness, edema, and glazing; bleeding on probing.
    3. Severe inflammation. Marked redness and edema, ulceration, and tendency toward spontaneous bleeding.

    Measured: - Screening (Visit 0b) - 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)

  7. 7.2 Clinical measurements - Probing Pocket depth (PPD

    Probing Pocket depth (PPD) of the implant at 4 sites (M, D. B, L/P) - using a plastic probe.

    The scale start at 1mm and can range until 15 mm.

    Measured: 3 months ±14 days (Visit 3) 6 months ±2 weeks (Visit 5) 12 months ±2 weeks (Visit 6)]

  8. 7.3 Clinical measurements - Bleeding on Probing

    Bleeding on Probing (BoP) of the peri-implant tissue at 4 sites (M, D. B, L/P) - using a plastic probe Scale - presence or absence of bleeding

    Measured: 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)

  9. 7.4 Clinical measurements (using UNC periodontal probe)

    Suppuration of the peri-implant tissue at 4 sites (M, D. B, L/P) - using a plastic probe.

    Scale - presence or absence of suppuration.

    Measured: 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)

  10. Safety Measurements - Avaluation

    At each visit, scheduled or unscheduled, the subject will be asked an open question: "Have you had any oral or general health problems since the previous visit?"

    Measured: - 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07498556
Sponsor's protocol ID
35/2025
Acronym
CT
Status last verified
Feb 2026
First submitted
19 Mar 2026
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Test group - Implant restoration with a temporary crown in people with Dental Implants and Immediate Dental Implant Loading, run by Universidade do Porto at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ricardo Faria Almeida, Full Professor (+351220901100, ralmeida@fmd.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant survival rate (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in