Edentulous Alveolar RidgePhase 2NCT06784050
Impact of Two Occlusal Schemes in Implant Retained Mandibular Overdenture on the Masticatory Efficiency
A Phase 2 study testing Bilateral Balanced Occlusion and Monoplane Occlusion in people with Edentulous Alveolar Ridge, run by Ain Shams University at 1 site in Egypt.
Trial summary
Purpose: To assess the effect of two different occlusal schemes, bilateral balance and monoplane on the masticatory efficiency in mandibular implant retained overdenture with ball and socket attachment. Methodology: Twelve male completely edentulous patients were recruited for this clinical study. Read more about this study
- Who is it for?
- Ages 55 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Bilateral Balanced Occlusion and Monoplane Occlusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Sep 2024to 20 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
outpatient clinic of the Prosthodontic Department, Faculty of Oral and Dental Medicine, Ahram Canadian University.
Cairo, Cairo Governorate, 11277
About this study
Purpose: To assess the effect of two different occlusal schemes, bilateral balance and monoplane on the masticatory efficiency in mandibular implant retained overdenture with ball and socket attachment. Methodology: Twelve male completely edentulous patients were recruited for this clinical study. Each patient received two implants after that. Patients were divided randomly into two equal groups according to occlusal schemes which involved bilateral balanced occlusion and mono plane occlusion. each. Group 1 received a bilateral balanced occlusion scheme denture; Group 2 received monoplane occlusal scheme denture. Masticatory efficiencies were evaluated by assessing chewing time and number of chewing strokes with different types of foods. The data were collected, tabulated and statistically analyzed. Results: using dentures with bilateral balanced occlusion showed lower masticatory efficiency than the denture with monoplane occlusion with no significant difference when using soft food during the first month, while after 3 months there were significant differences between the two groups. Conclusion: The two-implant retained mandibular overdenture with monoplane occlusion showed relatively improved masticatory efficiency than with bilateral balanced occlusion.
Read the 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
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Bilateral Balanced Occlusion, Monoplane Occlusion
- Keywords
- dental implant overdenture, occlusal scheme, masticatory efficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Balanced OcclusionProcedure or surgery
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.
Monoplane OcclusionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Balanced Occlusion Group | Active comparator | 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. Receives: Procedure: Bilateral Balanced Occlusion |
| Monoplane Occlusion Group | Experimental | 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 Receives: Procedure: Monoplane Occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masticatory Efficiency Using Soft Food
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.
Measured: Assessments were made at three points, baseline, after one month and three months from the start of using the overdentures.
Masticatory Efficiency Using Hard Food
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.
Measured: Assessments were made at three points, baseline, after one month and three months from the start of using the overdentures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start22 Sep 2024
- Primary completion20 Nov 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma ElSayed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784050
- Sponsor's protocol ID
- IRB00012891#133
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Two Occlusal Schemes in Implant Retained Mandibular Overdenture on the Masticatory Efficiency
- ClinicalTrials.gov ID
- NCT06784050
- Acronym / sponsor ID
- IRB00012891#133
- Conditions
- Edentulous Alveolar Ridge
- Keywords
- dental implant overdenture, occlusal scheme, masticatory efficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Sep 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To assess the effect of two different occlusal schemes, bilateral balance and monoplane on the masticatory efficiency in mandibular implant retained overdenture with ball and socket attachment. Methodology: Twelve male completely edentulous patients were recruited for this clinical study. Each patient received two implants after that. Patients were divided randomly into two equal groups according to occlusal schemes which involved bilateral balanced occlusion and mono plane occlusion. each. Group 1 received a bilateral balanced occlusion scheme denture; Group 2 received monoplane occlusal scheme denture. Masticatory efficiencies were evaluated by assessing chewing time and number of chewing strokes with different types of foods. The data were collected, tabulated and statistically analyzed. Results: using dentures with bilateral balanced occlusion showed lower masticatory efficiency than the denture with monoplane occlusion with no significant difference when using soft food during the first month, while after 3 months there were significant differences between the two groups. Conclusion: The two-implant retained mandibular overdenture with monoplane occlusion showed relatively improved masticatory efficiency than with bilateral balanced occlusion.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral Balanced Occlusion Group | Active comparator | Procedure: Bilateral Balanced OcclusionThis 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. |
| Monoplane Occlusion Group | Experimental | Procedure: Monoplane OcclusionThis 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 |
Who may qualify
- Ages
- 55 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Balanced OcclusionDentures 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. | Procedure or surgery | Bilateral Balanced Occlusion Group |
| Monoplane OcclusionThis 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 | Procedure or surgery | Monoplane Occlusion Group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bilateral Balanced Occlusion and Monoplane Occlusion in people with Edentulous Alveolar Ridge, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.