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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Egypt

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

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 groups in NCT06784050
Study groupRoleWhat they receive
Bilateral Balanced Occlusion GroupActive comparatorThis 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 GroupExperimentalThis 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.

  1. 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.

  2. 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.

  1. First posted20 Jan 2025
  2. Study start22 Sep 2024
  3. Primary completion20 Nov 2024
  4. Study completion20 Dec 2024

Resources

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)
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

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.

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