Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06127017 |
Other study ID # |
1226 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 1, 2023 |
Est. completion date |
August 1, 2024 |
Study information
Verified date |
November 2023 |
Source |
Ain Shams University |
Contact |
soha s elsaeid |
Phone |
01066747918 |
Email |
sohasaeid[@]dent.asu.edu.eg |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Fourteen completely edentulous patients will be randomly allocated into two parallel arm
groups. For both groups virtual implant planning will be done and surgical guide will be
planned and printed. An immediate interim full arch PMMA prosthesis will be virtually
designed and printed for both groups. For the Intraoral welding group, seven patients will
receive immediately loaded interim fixed full arch prosthesis splinted by intraoral welded
bar. While for PEEK group in which seven patients will receive immediately loaded interim
fixed full arch prosthesis splinted by PEEK bar. Marginal bone loss will be clinically
evaluated at four, six months follow up period using CBCT.
Description:
Study settings The study will be conducted in Oral & Maxillofacial Prosthodontics Department,
Faculty of Dentistry, Ain Shams University. Sample size calculation Fourteen patients will be
selected to share in this study from the outpatient clinic of Prosthodontics Department,
Faculty of Dentistry, Ain-Shams University. G power program (3. 1) was used for calculations
of sample size. Statistical calculator was based on 95% confidence interval and power of the
study 80% with α error 5%.
Based on a previous study (Degidi, Marco, Diego Nardi, and Adriano Piattelli. "Prospective
study with a 2-year follow-up on immediate implant loading in the edentulous mandible with a
definitive restoration using intra-oral welding), which showed that the mean of marginal bone
growth was 0.21 in one group compared to the second group. Using un paired t test the results
were found to be significant. So, it was relied upon in this study. Based on this assumption,
sample size was calculated according to these values producing a minimal sample size of
fourteen patients being enough to find such a difference. Study procedures
1. Randomization and allocation concealment techniques Computer-generated random numbers
will be used for simple randomization of the subjects. Therefore, the participants will
be randomly allocated into two groups: intraoral welding group and PEEK group. The
allocation ration will be set 1:1. Allocation concealment will be done using opaque
sealed envelopes.
2. Details of intervention:
Ethical approval will be granted by the Research Ethical Committee, Faculty of Dentistry, Ain
Shams University (FDASUREC). All patients will be informed in details about the nature of
investigation and the aim of the study. Patient's data will be kept safe and confidential to
protect the security and privacy of the patient information. All participants will be given
notice about their privacy and their rights. 1-Patient Grouping: Fourteen patients will be
enrolled in this study and randomly divided into two groups as follow Group Ⅰ: seven patients
will receive immediately loaded interim fixed full arch prosthesis splinted by intraoral
welded bar. Group Ⅱ: seven patients will receive immediately loaded interim fixed full arch
prosthesis splinted by PEEK bar
2-Patient selection: The inclusion criteria will be systemically free completely edentulous
patient ranged from 45 y to 69 years old with Class I maxillary-mandibular relationship,
Normal salivary flow with normal viscosity. Residual maxillary ridge has adequate bone and
covered by firm healthy mucosa. The excluded patients will include patients with major
systemic diseases that may affect osseointegration as uncontrolled diabetes or under
bisphosphonate treatment, Patients with poor oral hygiene. Patients with abnormal oral habits
as (bruxism, clenching, tongue thrusting).Potentially uncooperative patients who are not
willing to go through the proposed interventions. 3-Clinical steps:
a. pre-surgical procedures: i. Patients' history: Medical history: Patients will be asked
about their medical and dental history through a direct interview and a detailed
questionnaire sheet. Dental history: Patients will be asked about the cause, the date of
teeth extraction and if there is any previous experience with any prosthetic appliance, any
problems with TMJ will also be recorded. ii. Patients' examination:
Extra oral examination:
Extraoral examination will be performed for the detection of any abnormal facial anomalies,
skin inflammation or lesions, any abnormalities in the TMJ as joint clicking, limitation in
mouth opening or pain, and checking the maxillo-mandibular relationship Intra-oral
examination: Visual and digital examination will be performed following routine procedures to
examine denture bearing mucosa, border tissues, abnormal soft tissue, tongue, frenula, muscle
tone, saliva, tori, sharp bony spicules, remaining teeth, arch relationship, ridge form,
inter-ridge space and undercuts..
Radiographic evaluation:
(CBCT) radiograph will be done to evaluate the degree of bone resorption, quality and
quantity of bone, to detect if there are remaining roots and any pathological lesions
Prosthetic procedures:
Properly constructed conventional single upper denture will be made for all patients. The
Conventional denture will be duplicated with radiopaque markers and CBCT will be used to
determine the exact positions of the implants. Virtual implant planning will be done using
the BlueSky Bio 4 software. A surgical guide will be planned and then the 3D virtual guide
will be exported as STL file to the 3D printing machine. An immediate interim full arch PMMA
prosthesis will be virtually designed and printed for both groups. For the second group a
PEEK bar will be virtually designed and printed. b. Surgical procedure: Surgery will be done
under local anesthesia. The surgical guide will be fixed in place. Six implants will be
placed according to the planned cone beam CT using surgical guide to accurately place the
implants. Implants will be distributed following the Misch protocol; two implants in the
first molar position, two implants in the canines position and two implants in the first
centrals position. Serial osteotomies will be performed using sharp drills under copious
irrigation to decrease heat generation until the planned depth and width will be reached.
The implant will be inserted through the osteotomy manually then continued using a ratchet
with 35 Ncm torque Multiunit abutments will be screwed to the implants according to the
Virtual implant planning. Titanium cylinders will be connected to the multiunit abutments.
Adjustment of the interim prosthesis and immediate loading:
All the pick-up procedures will be done in the same session of implant installation for both
groups.
1. For the intraoral welding group:
A titanium bar will be welded to titanium cylinders using an intraoral welding unit.
Then, pick up will be done for the printed interim PMMA prosthesis to the titanium bar.
2. For the PEEK group:
The virtually designed and printed PEEK bar will be cemented to the titanium cylinders using
flowable composite then, pick up will be done for the printed interim PMMA prosthesis to the
printed PEEK bar. 4-Method of evaluation: Implant marginal bone loss (MBL) will be the
difference in marginal bone level from the functional loading time with the interim
prosthesis (T0) to the end of the follow-up (T1after four months, T2 after six months)
.Marginal bone level around the implant will be measured from the CBCT scans made at T0, T1,
T2. Vertical buccal or lingual bone heights (VBBH or VLBH) and horizontal buccal or lingual
bone thicknesses (HBBT or HLBT) at the implant platform will be measured at themidsagittal
cut of each implant perpendicular to the dental arch on the CBCT scan.
The distance from the implant platform (the horizontal interface between the abutment and the
implant) to the most coronal point of bone-to-implant contact will be taken as the vertical
bone height. Measurements will be calibrated by using the actual known length of the implant.
Similarly, the vertical mesial or distal bone height (VMBH or VDBH) at the implant platform
will be measured at the midsagittal cut of each implant parallel to the dental arch on the
CBCT scan