Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622837
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Swallowing Threshold and Efficiency for Maxillary Implant Assisted Overdenture
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Within-subject Evaluation of Swallowing Threshold and Efficiency for Maxillary Implant Assisted Overdenture with and Without Palatal Coverage
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1 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
2 Two designs of MaxIODs
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
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
The participants were randomly allocated into two equal groups 7 per group Randomization process was carried out by an independent examiner using a computer program specifically Microsoft Excel The first group of 7 participants received conventional MaxIODs After a period of three months the TOMASS test was done Following this they wore a palatless MaxIODs for an additional 3 months after which the test was repeated The second group of 7 patients initially received palatless MaxIODs After three months of use the TOMASS test was done They then received conventional MaxIODs and the test was repeated after an additional three months This randomization process was implemented in order to minimize the effect of the order of restoration on the measurements of swallowing threshold and efficiency
Swallowing assessment
TOMASS test was utilized to assess participants39 swallowing abilities 30 For this study a commercially available cracker biscuit was used Participants were instructed to sit on a chair in upright position and to eat the biscuit comfortably and as quickly as possible They were also asked to say their name out loud as it indicate that they had finished the test Using a video recorder the procedure was recorded for further analysis
The recorded videos were then analyzed using the Avidemux 26 program to measure the following
1 Swallowing threshold which is the duration of chewing until the first swallow determined by the moment of laryngeal elevation
2 The TOMASS test parameters
1 Number of bites The number of discrete bites taken to finish the cracker
2 Number of masticatory cycles As each cyclical mandibular movement up-down
3 Number of swallows As each vertical movement of the thyroid cartilage
4 Total ingestion time The time taken to complete the ingestion of the cracker from the first bite to the last
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
1 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
2 Two designs of MaxIODs
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
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
The participants were randomly allocated into two equal groups 7 per group Randomization process was carried out by an independent examiner using a computer program specifically Microsoft Excel The first group of 7 participants received conventional MaxIODs After a period of three months the TOMASS test was done Following this they wore a palatless MaxIODs for an additional 3 months after which the test was repeated The second group of 7 patients initially received palatless MaxIODs After three months of use the TOMASS test was done They then received conventional MaxIODs and the test was repeated after an additional three months This randomization process was implemented in order to minimize the effect of the order of restoration on the measurements of swallowing threshold and efficiency
Swallowing assessment
TOMASS test was utilized to assess participants39 swallowing abilities 30 For this study a commercially available cracker biscuit was used Participants were instructed to sit on a chair in upright position and to eat the biscuit comfortably and as quickly as possible They were also asked to say their name out loud as it indicate that they had finished the test Using a video recorder the procedure was recorded for further analysis
The recorded videos were then analyzed using the Avidemux 26 program to measure the following
1 Swallowing threshold which is the duration of chewing until the first swallow determined by the moment of laryngeal elevation
2 The TOMASS test parameters
1 Number of bites The number of discrete bites taken to finish the cracker
2 Number of masticatory cycles As each cyclical mandibular movement up-down
3 Number of swallows As each vertical movement of the thyroid cartilage
4 Total ingestion time The time taken to complete the ingestion of the cracker from the first bite to the last
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None