SA Versus SOI Surfaces for Single Implant-supported Crown

Bone Resorption Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04073654
• Other study ID #: SOI_1_RCT_MT
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2019
• Est. completion date: October 15, 2021

Study information

• Verified date: September 2019
• Source: Osstem AIC
• Contact: Marco Tallarico
• Phone: +3280758769
• Email: me[@]studiomarcotallarico.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 15, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Resorption
• Dental Implant Failed

Intervention

Procedure:
• Placement of dental implants (surgical procedure)
The two study implants have to be placed in the same surgical session according to similar procedures. Implants will be placed in the planned anatomic sites by using a flapless or a miniflap approach. Implants sites will be prepared based on the bone density, and according to the manufacturers's instruction by using the 122 Taper kit (Osstem Implant).

Locations

Country	Name	City	State
Albania	Erta Xhanari	Tirana
Bulgaria	Elitsa Deliverska	Sofia
Italy	Fulvio Gatti	Milan
Italy	Studio Odontoiatrico Marco Tallarico	Rome
Italy	Leonardo Muzzi	Siena
Poland	Lukasz Zadrozny	Warsaw
Portugal	Cesaltino Remedios	Fatima
Romania	Mircea	Craiova
South Africa	Andre de Waal	South Africa
Switzerland	Nicolas Widmer	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Osstem AIC

Countries where clinical trial is conducted

Albania,  Bulgaria,  Italy,  Poland,  Portugal,  Romania,  South Africa,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant failure	Implant removal for any reason will be considered an implant failure.	From implant placement up to 60 months after loading
Primary	Crown failure	Crown replacement for any reason will be considered a crown failure.	From crown delivery up to 60 months
Primary	Complications	Any complications will be recorded. Examples of biological complications are: nerve injury, fistula, peri-implantitis. Examples of biomechanical complications are fracture of the abutments screw, loosening of the crown, fracture of the ceramic.	From implant placement up to 60 months after loading
Secondary	Peri-implant marginal bone level (MBL) changes	It will be assessed on periapical radiographs taken with the paralleling technique. The distance between marginal bone level and implant/abutment junction, will be measured at both mesial and distal sides and averaged. Bone level changes at single implants will be averaged at group level. Non-digital radiographs will be scanned, digitized, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known distance of the implant neck. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact.	From implant placement up to 60 months after loading
Secondary	Probing pocket depth (PPD)	Probing pocket depth will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant.	From crown delivery up to 60 months
Secondary	Bleeding on probing (BOP)	Bleeding on probing will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant.	From crown delivery up to 60 months
Secondary	plaque index (PI)	Plaque index will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA) at delivery of the definitive crowns, 1, 3, and 5 years follow-up in function. Three vestibular and three lingual values will be collected for each implant.	From implant placement up to 60 months after loading
Secondary	Implant stability quotient	The implant stability quotient will be recorded by the blind outcome assessor using resonance frequency analysis (Osstell Mentor; Osstell, Goteborg, Sweden).7 Buccopalatal and mesiodistal measurements will be taken and averaged, with the result being displayed by the device in ISQ units, ranging from 1 to 100.	The ISQ values will be recorded at the time of implant placement (baseline) and then 1,2,3,4,5,6,7,8, and 12 weeks after implant placement.
Secondary	Pink Esthetic Score	The aesthetic evaluation will be performed according to the pink aesthetic score on the vestibular and occlusal pictures taken including at least one adjacent tooth per side.8 The values will be assessed at definitive prosthesis delivery, and then early up to the end of the follow-up. Seven variables (mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture) will be assessed with a 2-1-0 score (2 being best and 0 being poorest) by the same blinded dentist.	From crown delivery up to 60 months