Within-subject Evaluation of Swallowing Threshold and Efficiency for Maxillary Implant Assisted Overdenture with and Without Palatal Coverage.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- swallowing evaluation
Study Overview
Brief Summary
This study aimed to compare the swallowing threshold and efficiency of conventional maxillary implant overdenture and palatless designs.
Detailed Description
New complete dentures were constructed for each participants using the conventional technique. The dentures were then inserted and adjusted according to a lingualized balanced occlusal scheme. The dentures were duplicated using clear acrylic resin material. Radiopaque gutta percha markers were placed on the labial, buccal, and lingual flanges of the clear resin duplicate at different axial planes to create a radiographic stent.
For each participant, dual scan was performed using cone beam computerized tomography ( i-CAT, Pennsylvania, USA). One scan was taken while the patient wore the radiographic stent, and the other scan was taken for the stent extra orally. These two scans were then superimposed to create an implant plan and construct stereolithographic surgical guides. With the assistance of these stereolithographic surgical guides and submerged surgical technique, 4 dental implants (IS III Active Implant, Neo BioTech) were placed in the canines and premolars regions of the maxillary arch, and 2 dental implants were placed in the canines region of the mandibular arch.
Each participants instructed to take Prophylactic broad spectrum antibiotic (875mg Amoxicillin and Clavulanic acid 125 mg) one hour before the surgery and for 7 days and rinsed their mouth with an antiseptic mouthwash (2% chlorohexidine) for 2 weeks after surgery. Additionally, non-steroidal anti-inflammatory drug (Diclofenac tablet 50 mg) was prescribed to control postoperative pain. One week after the surgery, the dentures were relived and relined with soft liner material (Mucosoft, Parkell, Edgewood. USA) and delivered to the participants. Follow-up visits were scheduled.
After the osseointegration period (3 months for the mandibular arch and 6 months for the maxillary arch), locator attachments (Neo Bio Tech) were screwed to the implants. Each patient received the following types of overdentures:
- One mandibular implant-retained overdenture: After reliving the mandibular denture, direct pick-up technique was used to incorporate the attachments housing into the fitting surface of the mandibular denture.
- Two designs of MaxIODs:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •patient had sufficient bone quantity in the area between the mental foramina, sufficient inter-arch space, normal maxilla-mandibular relation, and have been edentulous for at least one year
Exclusion Criteria
- •Patients with uncontrolled systemic diseases, parafunctional habits, temporomandibular joint disorders, and a history of head/neck surgery were excluded, as were smoking and those who undergo radiation therapy.
Arms & Interventions
group I conventional maxillary implant overdenture
Conventional MaxIOD: After relieving the conventional maxillary denture, direct pick-up technique was used to incorporate the attachments housing into the fitting surface of the conventional maxillary denture.
Intervention: implant overdenture (Procedure)
group II palatless maxillary implant overdenture
Palateless MaxIOD: The conventional maxillary denture was duplicated and the palatal part was cut out, finished, and polished. The fitting surface was relived and direct pick-up technique was used to incorporate the attachments housing into the fitting surface of the palateless maxillary denture.
Intervention: implant overdenture (Procedure)
Outcomes
Primary Outcomes
swallowing evaluation
Time Frame: after 3 months of overdenture insertion
TOMASS test was utilized to assess participants\' swallowing abilities
Secondary Outcomes
No secondary outcomes reported