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

NCT06252324 · tracked via the Priya Life Science Italy tracker

Sponsor

University of Bologna

Phase

Not applicable

Started

2023-01-01

Last updated

2026-02-27

Condition(s) studied

Bone Loss

Investigational drug(s) / intervention(s)

Prime taper implant + cover screwPrime taper implant + healing screw

Prime taper implant + cover screw: tissue level implant placement with the addition of a cover screw

Prime taper implant + healing screw: bone level implant placement with the addition of a healing screw

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Marginal bone level (MBL) around implants — immediately after implant insertion, 1 month, 3 months, 6 months, 12 months, 24 months and 36 months.
analysis of bone level variations at different time frames
implant survival rate — 12 months, 24 months, 36 months from insertion
number of implants still functional at the end of the follow-up

Trial sites (1)

Facility	City	Region	Status
Endodontic clinical section, DIBINEM, UNiversity of Bologna	Bologna	Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06252324 on ClinicalTrials.gov ↗ ← All trials in Italy