- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06784050
Impact of Two Occlusal Schemes in Implant Retained Mandibular Overdenture on the Masticatory Efficiency
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dental research has shown that implant-retained overdentures markedly improve the quality of life for edentulous patients [1]. Research has shown that two dental implants are sufficient to support a mandibular overdenture [2]. Considering the increasingly old age and systemic health complications of these patients, it is imperative that dental implant treatment include minimum intervention for both surgical and prosthetic maintenance after the delivery of the final prosthesis. This requires reducing the transmission of stress to the dental implants via the overdenture and its framework, hence assuring fewer maintenance procedures [3].
The attachment systems used in implant-retained overdentures may be categorized according to the splinting of the implants. The connection between the prosthesis and the implant is made using bar structures when dental implants are splinted. If the dental implants are not splinted, each implant is independently affixed to the prosthetic structure using technologies such as Locator, ERA, ball, O-ring, and different magnetic systems.[1] The choice of attachment type is influenced by the location of the dental implant, the required degree of retention, the morphology of the edentulous jaw, and the patient's motor dexterity. The preferred attachment types for overdentures are the Locator and ball systems due to their ease of application, minimal technical requirements, and lower costs compared to bar or magnet systems. There is ongoing research and development to improve attachment systems in dental implantology. [2] The occlusal scheme for overdentures affects the pattern of occlusal contact between opposing teeth during centric relation and mandibular functional movements. Consequently, the quantity and intensity of these contacts are crucial in determining the overall efficacy and comfort of the prosthesis. [3] The occlusal scheme known as fully bilateral balanced articulation is designed to ensure bilateral, simultaneous contact of the anterior and posterior denture teeth in both centric and eccentric positions. This scheme aims to achieve a cross-arch balanced articulation, promoting stability and functionality for the dentures during various mandibular movements.[4] On the other hand, the monoplane concept, first proposed by De Van in 1954, utilizes zero-degree teeth and creates a perfectly flat occlusal plane that is parallel to and evenly divides the upper and lower residual ridges. The occlusal plane is positioned at the junction of the upper and middle third of the retromolar pad. This approach eliminates inclined planes both in the tooth form and the occlusal plane, ensuring that no lateral components are generated with vertical chewing forces.[5] Masticatory performance refers to the ability to triturate food under controlled testing settings. [9] These food crushing tests are designed to evaluate the fragmentation of test specimens into smaller fragments. The test specimens may consist of natural food products, such as carrots or nuts, or synthetic materials like silicone-based Optosil cubes or fuchsin beads .[6] Masticatory efficiency is the primary indicator of mastication function and reflects the functional potential of the dental system, including dentures. Assessment the masticatory efficiency is vital for a comprehensive evaluation of treatment outcomes involving implant-retained overdentures.[7] Electromyographic devices are research equipment for evaluating the electrical activity of the muscles. The behavior of masticatory muscles and information as to the functional state of the stomatognathic neuromuscular system can be obtained by electromyography. It is a practical and efficient method for the study of muscle function and activity, thus serving as a valuable tool in dental research
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Cairo, Egypt, 11277
- outpatient clinic of the Prosthodontic Department, Faculty of Oral and Dental Medicine, Ahram Canadian University.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Male patients Completely edentulous Ages range from 55-60 years Residual alveolar ridges of maxilla and mandible covered by healthy, firm, compressible mucosa Free from any temporomandibular joint disorders Have Angle's class I jaw relation Edentulous mandible for at least 6 months No bone augmentation requirement Good oral hygiene
Exclusion Criteria:
Presence of any systemic conditions that could compromise implant surgery History of chemotherapy or radiotherapy to the head and neck region History of taking bisphosphonates Heavy smoker status
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Bilateral Balanced Occlusion Group
This group received dentures designed with a bilateral balanced occlusion scheme.
This occlusion scheme aims for simultaneous contact of teeth across the dental arch during jaw movements, purported to enhance stability and comfort.
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Dentures designed under this scheme feature a fully bilateral balanced articulation, ensuring bilateral, simultaneous contact of the anterior and posterior denture teeth in both centric and eccentric positions.
This occlusal scheme is aimed at promoting stability and functionality of the dentures during various mandibular movements.
|
|
Experimental: Monoplane Occlusion Group
This group received dentures designed with a monoplane occlusion scheme.
This scheme involves a flat occlusal plane without curvature, intended to reduce the complexity of denture fabrication and potentially improve masticatory efficiency by simplifying the occlusal contacts
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This scheme utilizes zero-degree teeth to create a flat occlusal plane, which is designed to simplify the occlusal contacts and minimize the transmission of lateral forces during mastication.
The aim is to improve masticatory efficiency by reducing the complexity of tooth contact
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Masticatory Efficiency Using Soft Food
Time Frame: Assessments were made at three points, baseline, after one month and three months from the start of using the overdentures.
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The masticatory efficiency was assessed by measuring the number of chewing strokes and the time taken to achieve the first swallow and complete mouth clearance while chewing standardized pieces of soft food.
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Assessments were made at three points, baseline, after one month and three months from the start of using the overdentures.
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Masticatory Efficiency Using Hard Food
Time Frame: Assessments were made at three points, baseline, after one month and three months from the start of using the overdentures.
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Similar to the soft food assessment, the efficiency for chewing hard food was evaluated by counting the number of chewing strokes and timing the duration until the first swallow and until the mouth was cleared of food.
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Assessments were made at three points, baseline, after one month and three months from the start of using the overdentures.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00012891#133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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