Active — Not RecruitingNot Applicable

Success and Survival Rate of Tranmucosal Versus Bone Level Implants: Randomized Clinical Trial

Italy80 participantsStarted 2023-01-01

Plain-language summary

The purpose of this study is to assess changes in peri-implant tissues and the effectiveness of a tissue-level surgical technique. This technique will be compared with a bone-level surgical technique. This is a post-marketing clinical investigation conducted in the Endodontics Department of the Dental Clinic at the University of Bologna. Patient recruitment and study conduction will follow the principles of the Declaration of Helsinki and adhere to major international guidelines (CONSORT). Implants will be placed using either a bone-level or tissue-level surgical technique, corresponding to implants positioned at the level of the gingival mucosa or submerged implants, respectively. Randomization (1:1 ratio) will be conducted before surgery to create two treatment groups. The experimental group (Tissue Level) (n=40) consists of implants that will be placed with the exposed neck (Tissue-level surgical technique). The control group (n=40) comprises implants placed at the bone level (Bone-level surgical technique). The surgeon will be aware of patient assignment during the implant insertion procedures. The surgical procedure to uncover the implant neck (control group) will be performed 3 months after implant placement. The experimental group (Tissue Level technique) will not require a surgical intervention. he following parameters will be assessed at 1, 6, 12, and 36 months after implant placement: Peri-implant parameters: Plaque score, Bleeding on Probing (BoP), and Papilla Index Radiographic parameters: Marginal Bone Level (MBL) Patient-Reported Outcome Measure (PROM): Post-operative pain (VAS) in the experimental group (non-submerged surgical technique) and the control group (submerged surgical technique).

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18-75 years; * Healthy or with mild functional limitations according to ASA classification 1-2 (16); * Consumption of fewer than 10 cigarettes per day; * Need for implant rehabilitation in a single-tooth edentulous area; * Presence of adequate volumes of bone tissue (3.5mm thickness and 9mm height) to allow proper implant placement and optimal primary stability. Exclusion Criteria: * Age under 18 years; * Medical and/or general contraindications to surgical procedures (ASA score ≥3) (16); * Poor oral hygiene and lack of motivation and/or active clinical periodontal disease expressed by probing pocket depth \>4 mm and bleeding on probing; * Smoking more than 10 cigarettes per day; * Systemic or local diseases that could compromise post-operative healing and osseointegration; * Alcohol and/or drug abuse; * Pregnancy or breastfeeding; * Malocclusion and other occlusal disorders; * Bisphosphonate therapy.

What they're measuring

Marginal bone level (MBL) around implants

Timeframe: immediately after implant insertion, 1 month, 3 months, 6 months, 12 months, 24 months and 36 months.

implant survival rate

Timeframe: 12 months, 24 months, 36 months from insertion

Trial details

NCT IDNCT06252324

SponsorUniversity of Bologna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31