Comparison Between Two Different Tissue-Level Implant Systems: A Prospective Clinical Study

NCT04761445 | Completed

• 1 other identifier: FMD187
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this prospective study is to compare clinically and radiographically two different tissue-level implants, in partially edentulous patients in the posterior area of the maxilla and mandible. The primary objective of the study was to track the crestal bone level changes around the two implant systems. Secondary objectives were implant stability as well as initial soft tissue thickness which were evaluated throughout this study.

Conditions

Peri-implant Bone Loss; Implant Stability; Vertical Soft Tissue Thickness

Keywords

Marginal bone loss; Crestal bone stability

Outcome Measures

Primary Outcomes (1)

• Crestal bone level changes.

  Peri-implant CBL changes were assessed using periapical radiographs. Radiographs were taken according to the long cone, paralleling technique, using a positioner (XCP Rinn holders, Dentsply Friadent Schweiz, Nidau, Switzerland) parallel to the implant axis and perpendicular to the cone of rays. An individualized radiographic mount (foam and acrylic) was used for each patient to standardize the periapical radiographs. This technique allows the repositioning of the image plate in future radiologic examinations. For the digital process, an image measuring program, Image J (Wayne Rasband, National Institutes of Health) was used.

  Radiographic evaluation took place at three time periods: at implant placement, at implant loading and one year after implant loading.

Secondary Outcomes (2)

• Initial soft tissue thickness.

  Vertical soft tissue thickness was measured immediately during the implant placement.

• Primary and secondary implant stability.

  Primary and secondary implant stability were measured immediately after implant placement (t1) and after 3 months (t2) respectively.

Study Arms (2)

Straumann Standard Plus (SP)

EXPERIMENTAL

Patients receiving Straumann SP implants of 4.1 mm in diameter and length of 10 mm.

Other: Straumann Standard Plus implant and JDental care (JD) Octa implant

JDental care Octa (JD Octa)

EXPERIMENTAL

Patients receiving JD Octa implants of 4.3 mm in diameter and 10 mm in length.

Other: Straumann Standard Plus implant and JDental care (JD) Octa implant

Interventions

Straumann Standard Plus implant and JDental care (JD) Octa implant OTHER

Two different implant systems were used. The above-mentioned implants share many features in common, such as implant design. They both have a machined implant collar of 1.8 mm.

Also known as: Straumann SP implants, JD Octa implants (J Dental Care)

JDental care Octa (JD Octa); Straumann Standard Plus (SP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 18, requiring placement of at least two adjacent implants in the posterior maxilla or mandible (premolar-molar area)
• Patients willing to sign the consent form and respect the follow-up period of the study
• Non-smokers or light smokers (less than 10 cig/day)
• No bone augmentation procedures before or during implant placement in the area of interest
• Healthy soft tissue conditions (full mouth plaque scores \< 20% and full mouth bleeding index \< 20%)
• Minimum height of 2 mm of keratinized tissue
• Minimum of 6 mm in bone width and 10 mm in bone height
• Minimal distance of 2 mm between predicted implant tip and inferior alveolar nerve
• Healed sockets (at least 4 months post-extraction)

You may not qualify if:

• Patients with any local or systemic disease
• Patients taking any kind of medication that interferes with bone metabolism
• Pregnant or breast-feeding women
• Patients with parafunctional disorders
• Patients with poor oral hygiene
• Heavy smokers (\>10 cig/day)

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University (USJ)

Beirut, 17-5208, Lebanon

Location

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Carole Chakar, DDS, PhD

  Head of the department of periodontology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The day of the surgery, each implantation site was given a number depending on the tooth missing. Then, using a random team generator software (Keamk) each site was randomly assigned to one of the two groups based on the implant system used. Participants were blinded as to the assignment in the first or second group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study is designed as a prospective clinical trial with a parallel design comparing two different tissue-level implants placed adjacently in the posterior maxilla and mandible.

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: February 21, 2021
• Study Start: January 10, 2019
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)