SA Versus SOI Surfaces for Single Implant-supported Crown

Not Applicable

• Conditions: Dental Implant Failed; Bone Resorption
• Interventions: Procedure: Placement of dental implants (surgical procedure)

• Registration Number: NCT04073654
• Lead Sponsor: Osstem AIC

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.

Study Timeline

• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-29
• Status Verified: 2019-09
• Study Start: 2019-09-26
• Last Update Submitted: 2019-09-29
• Last Update Posted: 2019-10-01
• Primary Completion: 2020-09-30
• Study Completion: 2021-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SA Implants	Placement of dental implants (surgical procedure)	Dental implant with sandblasted and Acid-etched (SA) surface
SOI Implants	Placement of dental implants (surgical procedure)	Same dental implant with sandblasted and Acid-etched surface modified with pH buffering agent

Primary Outcome Measures

Name	Time	Method
Implant failure	From implant placement up to 60 months after loading	Implant removal for any reason will be considered an implant failure.
Crown failure	From crown delivery up to 60 months	Crown replacement for any reason will be considered a crown failure.
Complications	From implant placement up to 60 months after loading	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.

Secondary Outcome Measures

Name	Time	Method
Peri-implant marginal bone level (MBL) changes	From implant placement up to 60 months after loading	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.
Probing pocket depth (PPD)	From crown delivery up to 60 months	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.
Bleeding on probing (BOP)	From crown delivery up to 60 months	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.
plaque index (PI)	From implant placement up to 60 months after loading	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.
Implant stability quotient	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.	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.
Pink Esthetic Score	From crown delivery up to 60 months	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.

Trial Locations

Locations (10)

Elitsa Deliverska; 🇧🇬 Sofia, Bulgaria

Erta Xhanari; 🇦🇱 Tirana, Albania

Łukasz Zadrożny; 🇵🇱 Warsaw, Poland

Cesaltino Remedios; 🇵🇹 Fatima, Portugal

Mircea; 🇷🇴 Craiova, Romania

Studio Odontoiatrico Marco Tallarico; 🇮🇹 Rome, Italy

Leonardo Muzzi; 🇮🇹 Siena, Italy

Andre de Waal; 🇿🇦 South Africa, South Africa

Nicolas Widmer; 🇨🇭 Bern, Switzerland

Fulvio Gatti; 🇮🇹 Milan, Italy