Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03887975 |
| Other study ID # |
Ain Shams heba tarek |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 20, 2018 |
| Est. completion date |
February 1, 2019 |
Study information
| Verified date |
March 2019 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Materials and methods: fourteen patients were selected according to the inclusion criteria,
the participants were stratified equally into two groups, patients were assigned to receive
either monoplane or lingualized occlusal schemes to their overdentures. For each patient
placement of two mini-implants in the mandible at the canine region was done, bar joint
attachment was used to splint the mini implants. Each implant was 2.5 mm in diameter and 10
mm in length. T-scan occlusal load analysis records were done in centric occlusion , the
records was used to analyze the biting force of the denture as a Full Closure Force Movie
recording, then Time vs. Force Graph of that Force Movie is accomplished. T-scan records were
taken three times for each patient in the two groups ,Immediately after loading ,three months
and six months of loading.
Description:
Fourteen completely edentulous patients will be selected from the outpatient clinic of
removable Prosthodontics Department, Faculty of Dentistry, Ain Shams University.
Patient's approval:
All participants were informed in details about the nature of the research and the purpose of
the study. They should agree to take part in it and sign an informed consent form.
All reasonable measures to protect the security of the personal information and privacy of
the patient protected health information will be taken.
All participants were given notice about their practices and their legal duties and rights.
All participants were informed about their benefits from the research that will be a
well-fitting and retentive denture In case of failure of the treatment the patient were
informed that a regular complete dentures will be constructed. All data were kept
confidential.
Grouping of patients:-
Patients were randomly divided into two equal groups,each group include:
Group (1): seven patients rehabilitated by bar retained mandibular overdenture with
lingualized occlusal concept supported by two mini implants.
Group (2): seven patients rehabilitated by bar retained mandibular overdenture with monoplane
occlusal concept supported by two mini implants.
Patient examination:
Thorough general and oral examinations were carried out to ensure acceptable conditions for
the proposed mini-implant treatment
Oral examination:
Visual and digital examinations were thoroughly carried out to assess the condition of
intra-oral tissues and ensure that the patients are suitable for the future surgical and
prosthetic procedures.
Construction of complete dentures with lingualized and monoplane occlusal schemes:
For all patients Upper and lower primary impressions were made by using compound impression
material . The impression were poured into plaster and acrylic special trays were
constructed. Border molding with green stick compound and final impressions for upper and
lower ridges were done by using Zinc oxide an eugenol impression material to obtain master
casts . Occlusion blocks on the master casts were constructed.
For lingualized group :
face bow record was made to mount the maxillary casts on a semi-adjustable articulator
.Centric occluding relation was recorded at the correct occlusal vertical dimension using
check bite technique to mount the lower cast on the articulator .
Protrusive record was made to adjust the horizontal condylar guidance of the articulator and
the lateral condylar guidance was adjusted according to Hanau's formula (L=H/8+12).
Setting up of the teeth was done using acrylic teeth according to the lingualized concept of
occlusion as follow: Anterior teeth were set according to esthetics, phonetics and lip
support, Lingual cusps of mandibular posterior teeth were placed medial to the lines drawn
from the tip of the canine to both sides of the retromolar pad. The mandibular posterior
teeth were placed with no transverse inclination (no Monson curve). The interlocking
transverse ridges of the occlusal surface were ground to provide freedom in occlusion (long
centric). Maxillary posterior teeth were modified to eliminate buccal cusp contact both in
centric and eccentric positions. The upper posterior teeth were arranged with their palatal
cusps in the modified central fossae of the lower posterior teeth. In lateral excursions, the
posterior teeth were arranged and adjusted to establish bilateral balanced occlusion.
Waxing up of the denture bases was done and try-in was made and the occlusion was carefully
checked on the articulator as well as in the patient mouth, the occlusion checked both in
centric and eccentric positions.For monoplane group:
Jaw relation was recorded using check bite technique then setting up of the teeth was done
according to the monoplane concept of occlusion as follow : Artificial teeth were used after
flattening of the cusp inclines. The teeth were arranged anteroposteriorly parallel with the
plane of denture foundation. The teeth were arranged mediolaterally with no medial or lateral
inclination. The lower second molars were kept out of occlusion. The upper and lower anterior
teeth were arranged to establish zero degree incisal guidance.
Waxing up of denture was made and try in was done then occlusion was carefully checked .
for all patients dentures: Flasking, packing and processing were done for waxed up dentures.
Laboratory remounting was carried out to correct any occlusal discrepancy from denture
processing. Finishing and polishing of the dentures were carried out after their removal from
the casts and the dentures were delivered to the patients.
Pre operative cone beam were made to all the patients to Locate the position of mental
foramina, identify and measure the anterior loop of mental nerve, measure the inter-foraminal
distance and determine the prospective position of mini-implants equi-distant on each side
from the midline by using clear acrylic surgical stent duplicated from the lower denture with
gutta percha attached to the proposed implant sites.
patients were instructed to take the following pre-surgical medications: Antibiotic
(Clavulanate-Potentiated Amoxycillin 1gm) every 12 hours started the day before surgery and
continued for one week, Analgesic and anti-inflammatory drug (Diclofenac Sodium 50mg) every 8
hours started 1 hour before surgery and continued for one week, Mouth wash (Chlorohexidine
Gluconate ) every 8 hours started the day before surgery and continued for one week. Patients
were instructed to rinse with Chlorohexidine Gluconate mouth wash at the time of the
operation. Bilateral mandibular nerve block (Articaine Hydrochloride 4% with Epinephrine
1:100,000) was administrated, with infiltration anesthesia at the surgical field.
The Surgical stent was used to guide the insertion of the two mini implants in the anterior
area between the two mental foramina, where a probe was entered in each hole and piercing the
mucosa leaving a bleeding points.
At the marked implant site, tissue punch was used to remove the soft tissue prior to the use
of the pilot drill . A 1.3 mm pilot drill was lightly pumped up and down vertically
perpendicular to the occlusal plane through the holes of the surgical stent, penetrating the
crestal bone 3-4 mm.
Sterile internal and external saline irrigation was used throughout the drilling procedure.
The pilot holes were deepened to a depth of the implants to be placed using osteotomy drill
of 10 mm. The MDI vial was opened and the mini implant 2.5mm diameter, 10mm length was
carried to the osteotomy site, and was rotated in a clockwise direction while exerting a
slight downward pressure using a finger rachet driver. The wrench torque was connected to
rachet driver (with the directional arrow facing a clockwise).
The final stage of the MDI placement was carried out with a careful controlled turns for
complete seating, 1/4 turn rotation with 15 seconds pauses between rotations Mini-implant
placement was completed with the protrusion of the full length of the abutment head from the
mucosa, but with no thread portions visible.
The square head of implants trimmed to the first mark that allow fixed abutment heights
suitable for the available inter arch space for all patients groups.
Bar attachment construction:
Closed tray impression was made with rubber base putty impression material using plastic
Transfer coping and implant analogue. Stone was poured to get cast with implant analogue in
its place representing patient's mouth. Metal custom made bar constructed splinting the two
mini implants.
Bar cemented with self adhesive resin cement "G-Cem capsule" and excess removed around the
bar and mucosa. A fast-setting chair side Poly-vinyl siloxane material (PVS) was loaded onto
the fitting surface of the lower denture , then it was seated in the patient's mouth to
locate the position of the bar, after few minutes the denture was removed from the patient's
mouth and area marked by the bar removed using large round bur. The denture was inserted in
the patient's mouth to ensure that it was passively seated.
Small amount of putty PVS used to block under and around the bar for pick up procedure .Clip
seated in it's place and Auto-polymerizing acrylic resin in dough stage was applied in the
space created in the denture opposite to the bar clip, and the overdenture was seated on the
model. Firm steady pressure was applied on the overdenture bilaterally till complete curing
of the resin. The excess material was trimmed and smoothened.
T-scan occlusal stress distribution recording:
T-Scan device was used, the Device consists of:
Scan handle and lab-top. Box of large and box of small sensors. Box of large and box of small
sensor supports. The sensor support provided enough width to cover the molars and the
patients were allowed to close comfortably, tried in to choose the correct support size.
sensors support was attached to the T-Scan handle with the "Sensor Position Guide" faced up
until it clicks into place. The latch was lifted and the sensor was inserted, which were the
same size as support, so that the outside edges of the sensor slide into the sensor support
channels then the latch was closed to lock the center in place.
A green light indicated that the sensor was properly connected.
Patient Record:
Records done in centric position by the following steps:
Patient record was created by clicking "New Patient", and the patient information, first,
middle and last name, gender, date of birth and ID number was filled.
The sensor was inserted into the mouth like that in impression tray. Patient opened his/her
mouth slightly. The sensor was inserted so that the position guide touch the central incisor
at the mid line. The sensor was held in place so that the sensor level with the occlusal
plane.
T-Scan device show range of colors to differentiate the forces on the teeth, Adjusting
sensitivity to ensure the entire color spectrum is used to visualize the differences in these
forces and that the maximum forces are within the sensor forces range, and this was done by:
- The patients were asked to bit and clench firmly. The patients were asked to clench and
the tooth contact was observed on the screen. The ideal setting is maximum 3 pink
contact.
- Records taken at centric positions
Rechecking occlusion and occlusal load equilibration in patients mouth:
Patients were frequently recalled for inspection, post insertion adjustments, future denture
relining and T-scan measurements done to assess occlusal forces immediately after loading, at
3 and 6 months after loading.
After three months of loading patients of lingualized group complained from denture movement
in the posterior region.
Chair side soft liner was added to the fitting surface of the dentures to adjust the
posterior occlusion and to comfort the patients. They were guided to close in centric
position till the soft liner material set . The occlusal equilibration were checked and
t-scan records made to measure occlusal stresses distribution.
