- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04761445
Comparison Between Two Different Tissue-Level Implant Systems: A Prospective Clinical Study
Study Overview
Status
Intervention / Treatment
Detailed Description
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. The primary outcome is the change in the interproximal crestal bone level.
Patients in this study were recruited from the general population attending the department of Periodontology at the Saint-Joseph University. Adult patients (males and females) in need of implant rehabilitation for partial edentulism in the posterior maxilla and mandible have been selected to take part in this study. Following initial screening procedures, each patient underwent a site-specific intraoral and radiographic examination (Cone Beam Computed Tomography analysis and periapical radiographs) in order to make sure that the inclusion criteria were satisfied. Patients presenting with bone width of less than 6 mm or more than 9 mm were immediately excluded from the study. The day of the surgery, each implantation site was given a number depending on the tooth missing. Then, using a random team generator software each site was randomly assigned to one of the two groups based on the implant system used:
The first group (group 1) consisted of patients receiving Straumann Standard Plus (SP) implants of 4.1 mm in diameter and length of 10 mm.
The second group (group 2) included patients receiving JD Octa implants of 4.3 mm in diameter and 10 mm in length.
Participants were blinded as to the assignment in the first or second group. The implant placement procedures were planned based on clinical and radiographic evaluation.
The following parameters were monitored for each case:
Crestal bone level changes (CBL)
Primary and secondary implant stability
Initial soft tissue thickness
After a healing time of 3 months Patients were recalled 6 and 12 months after prosthetic treatment. At each visit, the restorations were evaluated for mobility, oral hygiene, peri-implant soft tissue conditions and patient satisfaction. Intraoral standardized radiographs were also taken at the 12-months follow-up visit to evaluate crestal bone level changes. CBL changes were defined as the difference between two consecutive CBL measurements. Secondary implant stability was evaluated. Impressions were taken at the implant level. Abutments were fixed on the implants with titanium screws.
In order to reduce the risk of bias in the study, all the implant-supported crowns were screw retained. However, in only one case, and due to prosthetic considerations, two implant-supported crowns were cemented using a temporary cement. In this case, the restorations were thoroughly checked for excessive cement.
Final restorations were delivered within 2 weeks of referral. Finally, standardized radiographs were taken to ensure abutment seating and check for residual cement (in the case of cemented crowns).
Patients were recalled 6 and 12 months after prosthetic treatment. At each visit, the restorations were evaluated for mobility, oral hygiene, peri-implant soft tissue conditions and patient satisfaction. Intraoral standardized radiographs were also taken at the 12-months follow-up visit to evaluate crestal bone level changes. As described previously, CBL changes were defined as the difference between two consecutive CBL measurements.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beirut, Lebanon, 17-5208
- Saint Joseph University (USJ)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Patients not satisfying the inclusion criteria
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Straumann Standard Plus (SP)
Patients receiving Straumann SP implants of 4.1 mm in diameter and length of 10 mm.
|
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.
Other Names:
|
Experimental: JDental care Octa (JD Octa)
Patients receiving JD Octa implants of 4.3 mm in diameter and 10 mm in length.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Crestal bone level changes.
Time Frame: Radiographic evaluation took place at three time periods: at implant placement, at implant loading and one year after implant loading.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial soft tissue thickness.
Time Frame: Vertical soft tissue thickness was measured immediately during the implant placement.
|
Vertical soft tissue thickness was measured with a periodontal probe (PCP-UNC 15; Hu-Friedy, Chicago, IL) placed at the center of the future implant site after full thickness buccal flap elevation.
|
Vertical soft tissue thickness was measured immediately during the implant placement.
|
Primary and secondary implant stability.
Time Frame: Primary and secondary implant stability were measured immediately after implant placement (t1) and after 3 months (t2) respectively.
|
Primary and secondary implant stability were measured with Osstell ISQ (Osstell AB, Gothenburg, Sweden).
|
Primary and secondary implant stability were measured immediately after implant placement (t1) and after 3 months (t2) respectively.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Carole Chakar, DDS, PhD, Head of the department of periodontology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FMD187
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Implant Stability
-
University of LisbonCompleted
-
Cairo UniversityRecruiting
-
Nourhan M.AlyCompletedEFFECT OF LOW-LEVEL LASER THERAPY ON STABILITY OF DENTAL IMPLANTS PLACED IN A FRESH EXTRACTED SOCKETDental Implant StabilityEgypt
-
University of BaghdadActive, not recruitingDental Implant StabilityIraq
-
Krishnadevaraya College of Dental Sciences & HospitalCompletedBone Density | Implant StabilityIndia
-
Cairo UniversityUnknownImplant Stability | Root Analog Implant | Conventional Root Form Implant | Non Restorabl Teeth
-
Azhar ALI ELSAYED SELEEMUnknownCrestal Bone Resorption | Implant Primary Stability | Implant Osseointegration
-
University of CaraboboCompletedImplant Stability
-
Cairo UniversityRecruiting
Clinical Trials on Straumann Standard Plus implant and JDental care (JD) Octa implant
-
Universidade Federal de GoiasITI International Team for Implantology, SwitzerlandCompletedMouth, EdentulousBrazil
-
CochlearCompletedHearing LossBelgium, Australia
-
Bausch & Lomb IncorporatedCompletedDiabetic Macular EdemaChina, India
-
CochlearAvania; QbD ClinicalRecruitingHearing LossBelgium, United Kingdom, Italy, Netherlands
-
Collin County Ear Nose & ThroatIntersect ENTCompletedChronic Sinusitis, EthmoidalUnited States
-
ENT and Allergy Associates, LLPIntersect ENTCompleted
-
University of PittsburghMerck Sharp & Dohme LLCCompletedPregnancy | Sexual Behavior | Opiate Addiction | Contraceptive BehaviorUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Neuroblastoma | Localized Resectable Neuroblastoma | Localized Unresectable Neuroblastoma | Regional Neuroblastoma | Stage 4S Neuroblastoma | Stage 4 NeuroblastomaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland