Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study

Jaw, Edentulous, Partially Clinical Trial

Official title:

Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807416
• Other study ID #: 02.2013.Piemonte.PROED
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2013
• Last updated: September 1, 2016
• Start date: March 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: Proed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Aim of the present study will be to evaluate if the platform switching and the flat abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided.

80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. After 6 to 12 weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2 more months, the definitive porcelain crown will be delivered. The final outcomes will be collected after 1 year from implant insertion.

Data will refer to the following timing:

T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each, with different implant/abutment design.

Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3 Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants + GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments On x-rays, the mesial and distal Marginal Bone Level will be measured and compared among and between the groups at the 4 different timing.

Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at T0, T1, T2 and T3. Data will be statistically analyzed.

Description:

BACKGROUND:

Platform switching is intended to preserve marginal bone around implants. Studies have shown that implants using an integrated platform switching demonstrate crestal bone loss as low as 0.37mm, and 30 to 50% reduction in crestal bone loss when compared to non-platform switching implants. Recently, a new design titanium abutment (Tissuemax IL) has been proposed to modulate the soft tissue integration around implant supported crowns. A new implant with a hybrid surface (T3) has been recently launched by Biomet 3i, providing both integrated platform switching (Prevail) or non platform switching (Standard Collar).

Aim of the present study will be to evaluate if the platform switching and the Tissuemax abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided.

MATERIALS & METHODS:

80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. Implants should be inserted in preexisting adequate bone volume, without the need for any bone augmentation technique. Implants will be inserted with a transmucosal healing (single-stage surgical procedure) with immediate connection of the healing abutment. After 6 to 12 weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2 more months, the definitive porcelain crown will be delivered. The final outcomes will be collected after 1 year from implant insertion.

Data will refer to the following timing:

T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each, with different implant/abutment design.

Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3 Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants + GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments The division into the 4 group will be randomized. Standardized intraoral radiograms will be done at T0, T1, T2 and T3. On x-rays, the mesial and distal Marginal Bone Level will be measured and compared among and between the groups at the 4 different timing.

Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at T0, T1, T2 and T3. Data will be statistically analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Healthy adult patients with partial edentulism

Exclusion Criteria:

• Current pregnant patients

• History of malignancy

• History of radiotherapy or chemiotherapy in the last 5 years

• Long term steroidal or antibiotic therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Procedure:
• implant insertion and abutment connection
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected

Locations

Country	Name	City	State
Italy	PROED, Institute for Professional Education in Dentistry	Torino	TO

Sponsors (1)

Lead Sponsor	Collaborator
Proed

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal Bone Level	On standardized intraoral radiograms, mesial and distal marginal bone level at implant surface will be measured	1 year after implant installation	No
Secondary	Probing Pocket Depth	Probing depth measured mesially, buccaly, distally and lingually at implant site	1 year after implant installation	No
Secondary	Bleeding on Probing	Bleeding on Probing measured mesially, buccaly, distally and lingually at implant site	1 year after implant installation	No