Osseointegration With a New Hydrophilic Surface

Dental Implant Stability Clinical Trial

Official title:

Does the New Hydrophilic Surface Have Any Influence on Early Success Rate and Implant Stability During Osseointegration Period? A Split-mouth, Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03649100
• Other study ID #: Osstem_002
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: May 30, 2019

Study information

• Verified date: June 2019
• Source: Osstem AIC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to compare implant stability of Hiossen ET III implants with its new hydrophilic surface (NH) and Hiossen ET III implants with the SA surface.

Description:

Patients required at least two teeth to be rehabilitated with a fixed, implant-supported restoration, consecutively enrolled. Patients randomly received Sandblasted and Acid-etched (SA) surface implants (SA group) or SA implants with a newly developed bio-absorbable apatite nano coating (NH group). Outcome measures were: implant and prosthetic survival rate, complications, insertion torque, and implant stability quotient (ISQ) measured at implant placement and every week up to 8 weeks after implant placement. Comparison between groups was made by unpaired t test, while comparison between each follow-up will be made by paired t tests to detect any change during the follow-up. Complications and failures were compared by using Fisher exact test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any healthy patients

• Aged 18 years or older

• Requiring at least two implants to be rehabilitated with a fixed implant supported restoration

• Full mouth bleeding and full mouth plaque index lower than or equal to 25%

• Sufficient bone to allow placement of at least 11.5 mm-long implants, and bone width of at least six to eight mm for the placement of a regular platform Hiossen ET III implant (Deutsche Osstem GmbH, Eschborn, Germany).

Exclusion Criteria:

• Positive medical findings

• Psychiatric therapy

• Pregnancy or nursing

• Smoking more than 10 cigarettes per day

• Insertion torque < 35 Ncm

• Untreated periodontitis

• Acute and chronic infections of the adjacent tissues or natural dentition

• Previous radiotherapy of the oral and maxillofacial region within the last five years

• Post-extractive implants (at least three months after tooth extraction)

• Absence of teeth in the opposing jaw

• Severe clenching or bruxism

• Severe maxillo-mandibular skeletal discrepancy

• Poor oral hygiene

Related Conditions & MeSH terms

• Dental Implant Stability

Intervention

Procedure:
• Implant placement
Conventional implant placement. Implant site development was prepared according to the manufacturer's instruction by the investigator, before knowing the randomized implant (NH or SA).

Locations

Country	Name	City	State
Italy	Nicola Baldini	Florence
Italy	Fulvio Gatti	Milan
Italy	Studio Odontoiatrico Marco Tallarico	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Osstem AIC

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant and prosthetic success rates	Success rates of the implants and prostheses were evaluated by an independent assessor (EX). An implant was considered a failure if it presented mobility, assessed after the osseointegration period by tapping or rocking the implant head with the metallic handles of two instruments, progressive marginal bone loss or infection, or any mechanical complications rendering the implant unusable, although still mechanically stable in the bone. A prosthesis was considered a failure if it needed to be replaced with another prosthesis.	4 months after implant placement (baseline)
Secondary	Technical or biological complications	Any biological complication, such as pain, swelling, and or suppuration, as well as any technical complication, such as screw loosening, fracture of the framework and/or the veneering material will be recorded during the follow-up period. Complications were evaluated and treated by the same surgeon (MT).	4 months after implant placement
Secondary	Implant stability quotient (ISQ)	Implant stability quotient (ISQ) values were recorded each week up to 8 weeks, and then after 12 weeks, using resonance frequency analysis (Osstell Mentor device, Osstell, Gothenburg, Sweden). Each implant was measured twice. First in a messy-distal direction and then in a buck-lingual direction. The mean value was recorded.	Each week (after implant placement) up to 8 weeks, and then 12 weeks (after implant placement)