Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02789956 |
| Other study ID # |
IIS-14-083 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2016 |
| Est. completion date |
September 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Institute Franci |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to evaluate:
Primary objective The primary objective of the present study is to evaluate the marginal bone
level changes when partially edentulous patients, treated with implants, received a
multiunits screw retained fixed dental prosthesis with a Co/Cr milled framework with an
Internal or External connection.
Secondary objective
1. Overall survival rate.
2. Soft tissue status by assessment of bleeding on probing (BoP) and probing pocket depth
(PPD) at baseline and after 1,3,5 years.
3. Prosthetic survival rates including screw or abutment loosening, framework or veneer
fractures.
Description:
A randomized pilot study is designed to determine marginal bone changes between patients
treated with a milled framework in Co/Cr if the connection is Internal or External for the
rehabilitation of a partially edentulous area with a multiunit screw retained bridge. The
investigation will be performed in one clinical centre affiliated to the Department of oral
and maxillofacial surgery, Faculty of Odontology, Malmö University . In this center the
clinician and the examiner will be the same person.
Following a screening examination, subjects who will meet the inclusion criteria, will sign
the Informed Consent and will be enrolled in the study. The period of patient enrollment will
begin on October 1st 2015 and ends September 31st 2016.
The patients will be randomized with a method based on the use of sealed opaque envelopes.
The cases will be assigned to two different treatment groups:
Group A- Co/Cr milled framework with internal connection (Test) Group B- Co/Cr milled
framework with external connection (Control)
-Pre-treatment Patient data, medical history, clinical and radiographic examination will be
recorded for each patient. Clinical photographs will be taken in frontal, occlusal and
lateral projections Periodontal, endodontic and open caries lesions will be treated prior to
implant installation. All patients will receive careful oral hygiene instructions and
training in self-performed plaque control measure.
Orthopantomogram at constant magnification and CT scan computed exams will be carried out.
Plaster models and diagnostic wax-up will be carried out.
-First Surgical Phase (Implant Installation) The patient will receive antibiotic prophylaxis
(Amoxicillin 1gr) one hour prior to surgery and after the completion of implant installation
until suture removal with 1gr three times a day. (If the patient is allergic to amoxicillin
the examiner prescribes antibiotics at his own discretion at the same posology).
The surgical treatment will be performed under local anaesthesia. In case of remaining teeth,
they will be extracted with conventional technique before implants' placement.
Implants will be placed according to the guidelines described in the Astra Tech Osseospeed
EV® manual "Surgical procedures", using a two-stage protocol.
Implant spinning during the positioning of the cover screw will be registered as positive, if
present, or negative.
The operation will be finalized by a careful adaption of the flaps by means of an accurate
suture in order to obtain a full periosteal coverage.
Intraoral clinical photographs before, during and after surgery will be taken.
-Post-operative care The patients will be instructed to rinse with chlorhexidine 0.12%
mouthrinse and will be told to rinse with the antiseptic solution three times a day for 2
weeks. The patients will be advised to take NSAIDs for pain relief at their own discretion.
Liquid and semisolid food will be prescribed for the first post-operative week, after which
the sutures will be removed.
Two weeks after the operation the denture will be properly relined until the second stage
surgery.
Patients will be controlled at third and sixth weeks.
-Prosthetic procedures After eight weeks (+ 2) of implants healing a second stage surgery
will be applied and Healing Abutment will be performed groups A while a Uni Abutment 33°
connection procedure will be performed. In group B.
Impression with a customized spoon and Impregum material will be taken after one week from
the second surgery and prosthetic procedure will be performed according to the Atlantis-Isus
Dentsply Astra-tech prosthetic manual recommendations.
After 6 weeks (+ 2) from impression the definitive fixed dental prostheses screw retained
multiunits bridge will be applied.
The prosthesis will be made to accomplish the normal hygienic procedures. All prosthetic
procedures will be made in accordance to the Astra Tech procedures & products manuals.
The length of bridge cantilevers will be duly calculated to minimize implant overloading
according to the Atlantis-Isus recommendations for both group.
-Post-prosthetic measurements Clinical measurements Clinical examinations will be performed
immediately following the installation of the definitive prosthesis (Baseline-Loading) and
after 1, 3, and 5 years. In particular, plaque and soft-tissue inflammation will be
registered. Clinical photographs will be taken at each interval point.
Plaque: the presence of plaque will be scored at each implant site as well as at level of the
remaining teeth on four surfaces (buccal, lingual/palatal, mesial, distal). The mean
percentage of plaque harboring surfaces will be calculated using the case as the unit.
Soft-tissue inflammation: the presence of soft-tissue inflammation (bleeding on probing) will
be assessed on buccal, lingual/palatal, mesial, distal aspects of each implant. The mean
percentage of inflamed sites will be calculated using the case as the unit.
- Radiographic measurements
Peri-apical radiographs will be taken at prosthesis insertion (Baseline) and after 1, 3, and
5 years.
The radiographs will be taken with an X-ray apparatus supplied with a long cone by the
examiner each visiting time. Rinn centrators will be used to ensure reproducibility in the
measurement of marginal bone level change.
The radiographic images will be analysed at the Department of Radiology of Sahlgrenska
Academy, Gothenburg University by experienced radiologists who will be otherwise not involved
in the study.
9. STATISTICAL ANALYSIS
Results will be presented by appropriate descriptive and inferential statistic. Demographic
and other baseline characteristics will be presented by means of descriptive statistics.
Continuous variables will be presented by means of number of observations (N), minimum (min),
median, maximum (max), mean and standard deviation (std). Discrete variables will be
presented by frequency and percentage.
