Immediate Restoration of a New Implant With High Primary Stability (CT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Implants; Immediate Dental Implant Loading
• Intervention / Treatment: Device: Test group - Implant restoration with a temporary crown; Device: Control Group

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ricardo Faria Almeida, Full Professor; Phone Number: +351220901100; Email: ralmeida@fmd.up.pt

Study Locations

• Portugal
  • Porto, Portugal, 4200-393
    • Faculdade De Medicina Dentaria da Universidade do Porto
    • Contact: Francisco Correia; Phone Number: +351220901100; Email: fcorreia@fmd.up.pt
    • Contact: Ricardo Faria Almeida, Full Professor; Phone Number: +351220901100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group - Implant restoration with a temporary crown; Immediately 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).	Device: 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.; Other Names: Test group; Implant restoration with a temporary crown
Active Comparator: Control Group - Healing abutment on implant; A healing abutment of no more than one mm above the soft tissue will be attached to the Connect with a hand screwdriver.	Device: 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.; Other Names: Healing abutment on implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	- 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	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.	- 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)
Implant insertion torque	Using a motor device or a torque-controlled hand rachet	Immediately at implant placement (Visit 1)
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.	- 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)	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.	- 12 months ±2 weeks (Visit 6)
7.1 Clinical measurements - Gingival index	Gingival index - Silness and Loe. Using a plastic probe Scale: 0: Normal gingiva. No inflammation, no bleeding.; Mild inflammation. Slight change in color, slight edema, but no bleeding on probing.; Moderate inflammation. Redness, edema, and glazing; bleeding on probing.; Severe inflammation. Marked redness and edema, ulceration, and tendency toward spontaneous bleeding.	- Screening (Visit 0b) - 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)
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.	3 months ±14 days (Visit 3) 6 months ±2 weeks (Visit 5) 12 months ±2 weeks (Visit 6)]
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	3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)
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.	3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)
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?"	- 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)

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: MIS Implants Technologies Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: dental implants; Marginal bone loss; Immediate loading; Delayed loading; Implant survival rate; Esthetic outcome evaluation
• Additional Relevant MeSH Terms: Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 35/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 12 months following publication of the primary results and ending 36 months after publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No