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ClinicalTrials.gov ID

NCT04073654

Lead Sponsor

Osstem AICOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

100Estimated

Last Update Posted

Oct 1, 2019Actual

Start Date

Sep 26, 2019Actual

Primary Completion Date

Sep 30, 2020Estimated

Completion Date

Oct 15, 2021Estimated

Official Title

Clinical Evaluation and Primary Stability of Early Loaded Implants With Sandblasted and Acid-etched Surface Versus Implants With SA Surface Modified With pH Buffering Agent: a Multicenter Randomized Controlled Trial

Brief Summary

The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown.

Detailed Description

This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegration. main benefits in clinical practice should be reduced treatment time.

• Dental Implant Failed
• Bone Resorption

• Placement of dental implants (surgical procedure)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

• Any partially edentulous subject requiring at least two single (preferable non-adjacent) implant-supported crowns, being at least 18 year old and able to sign an informed consent will be screened for eligibility. Bone volumes should allow the placement of two implants at least 8.5 mm (maximum 10 mm) long and 4.5 mm (minimum 3.5 mm) wide, with a minimal insertion torque of 30 Ncm. Implants can be placed in previous post-extractive socket or in augmented bone, if at least 4 to 6 months have passed from the extraction or from augmentation procedures.

Exclusion Criteria:

• Patients unable to commit to 5 years follow-up.
• General contraindications to implant surgery.
• Less then 4 mm of keratinised gingiva crestally (at the implant sites).
• Immune-suppressed/compromised patients.
• Patients irradiated in the head and/or neck.
• Uncontrolled diabetes.
• Pregnancy or lactation.
• Untreated periodontal disease.
• Poor oral hygiene and motivation (full mouth bleeding and full mouth plaque index higher than 25%).
• Addiction to alcohol or drugs.
• Psychiatric problems and/or unrealistic expectations.
• Patients with an acute infection or suppuration in the site intended for implant placement.
• Patients needing any form of tissue augmentation at implant placement.
• Immediate post-extractive implants (implants can be placed after a 3-month healing period).
• Patients treated or under treatment with intravenous amino-bisphosphonates.
• Patients referred only for implant placement if the follow-up cannot be done at the treatment center.
• Patients participating in other studies, if the present protocol could not be fully adhered to.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Osstem AICOTHER

fudy@libero.it+39 ‭339 6441920‬

leo@leomuzzi.com

gheorghitamircea@gmail.com