Occlusion and Dis-Occlusion Time in Mandibular Overdentures Supported by Conventional Versus Mini- Dental Implants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-70
SponsorAin Shams University
About this trial
The aim of the study will be comparing between the occlusion and disocclusion time in mandibular single overdenture supported with immediately loaded two conventional implants versus immediately loaded four mini-implants.
Research question Is there a difference in occlusion and disocclusion time between two mandibular single dentures, one supported by immediately loaded two conventional implants and the second one supported by immediately loaded four mini-implants? Primary outcome: occlusion and disocclusion time Secondary outcome: Kapur index The null hypothesis is that there is no difference between both treatment modalities on occlusion and disocclusion time.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
patients with completely edentulous mandibular ridges and fully dentate or partially dentate maxillary arch restored with fixed restoration,
enough inter-arch space to allow for prosthetic rehabilitation with lower implant-retained overdentures
good oral hygiene and motivation.
Disqualifiers
The excluded patients will be patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, pregnancy, patients under bisphosphonate treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
mini dental implant
Procedure/SurgeryFor group MI patient, four screw type one piece mini dental implants will be inserted in the predetermined implant sites in the symphesial region. The position of the two distal implants will be marked 6 mm mesial to each mental foramen. The position of the other two implants will be marked equidistant from the distal implants with and at least 5 mm apart
conventional dental implant
Procedure/SurgeryFor group CI patient, two screw type conventional implants will be inserted in the symphesial region.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: conventional implant supported mandibular overdentureActive comparator 1 intervention
Group B: mini-implant supported mandibular overdentureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
occlusion/dis occlusion time
Occlusal parameters: occlusion time (OT) and disocclusion time (DT) will be recorded for each patient. The patient will be asked to close on sensor in centric occlusion holding their teeth together for 1 to 3 seconds then start right eccentric movement until disoccluding their teeth. This will be repeated 4 times for the right excursion (DT-right) and 4 times for the left excursion (DT-left). OT, DT-right, and DT-left were then calculated by taking the averages of the recordings.
Time frame
1 yearSecondary outcomes
1
denture stability
stability of the over dentures will be assessed intra-orally by a single experienced examiner using the modified Kapur criteria (Olshan modification).
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov