Immediate Restoration of a New Implant With High Primary Stability

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.

• Implant success rate [Срок оценки: - 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 [Срок оценки: - 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)]
• Implant insertion torque [Срок оценки: Immediately at implant placement (Visit 1)]
• Marginal bone changes [Срок оценки: - 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) [Срок оценки: - 12 months ±2 weeks (Visit 6)]
• 7.1 Clinical measurements - Gingival index [Срок оценки: - 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 3 months ±14 days (Visit 3) - 6 months ±2 weeks (Visit 5) - 12 months ±2 weeks (Visit 6)]
• Safety Measurements - Avaluation [Срок оценки: - 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)]