Comparative Study of Mandibular Dentures Immediately Loaded on Implants or Mini-implants

Study Overview
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Brief Summary
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3 groups of immediately Loaded implant-supported overdenture patients will be evaluated (overdentures supported by two standard-sized implant, overdentures supported by 4 mini implant d: 3.2 mm ,overdentures supported by 4 mini implant d: 2.75 mm) regarding stability, masticatory efficiency, patient's satisfaction, oral health related quality of life, Peri-implant crestal alveolar bone loss.

Detailed Description
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The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures. The evaluations of the primary outcomes will be conducted before implantation and after (1 - 3 - 6 - 12 - 18), except Peri-implant crestal alveolar bone loss will be conducted only after (0 - 3 - 6 - 12 - 18).

Official Title
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Comparative Clinical and Radiographic Study of Mandibular Overdentures Immediately Loaded on Implants or Mini-implants Randomized Control Trial

Conditions
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Problem With Dentures

Intervention / Treatment
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* Other: implant-supported mandibular overdenture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the patient should be completely edentulous for at least 6 months. first class jaw relation. adequate bone for an implant length of at least 10 mm and diameter of at least 2.75 mm. the patients should be able to speak and write in arabic. Exclusion Criteria: 1) patients who received radiotherapy to the head or neck region for tumors. (2) a history of chemotherapy. (3) patients on long-term steroids, or bisphosphonates. (4) heavy smokers. (5) patients with physical and mental dis -abilities that interfere with the maintenance of implants. (6) uncontrolled systematic disease that could compromise implant surgery. (7) extreme bruxism. (8) infectious disease. (9) temporomandibular joint dysfunction.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M:2.75<br>12 Patients will be provided with 4 mini implant-supported mandibular overdentures d: 2.75 mm | Other: implant-supported mandibular overdenture<br>* The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.<br>|
| Experimental: M3.25<br>12 Patients will be provided with 4 mini implant-supported mandibular overdentures d: 3.25 mm | Other: implant-supported mandibular overdenture<br>* The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.<br>|
| Experimental: S3.75<br>12 Patients will be provided with 2 standard sized implant-supported mandibular overdentures d: 3.75 mm | Other: implant-supported mandibular overdenture<br>* The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in denture stability | The evaluation will be by Digital force gauge, a Hook of orthodontic wire (18 gauge diameter) will attach to the labial flange of overdenture, the other end of wire will connect to the force gauge which will be pull vertically upward until denture retention lost, and then reading will record 3 times and means value will calculate. | T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded | 
| change in masticatory efficiency | The evaluation will be by test food filtering device,Where the subjects will chew a measured portion of test food (peanuts) for 20 strokes. The test food will strain through mesh sieve (2 mm opening). The volume of food remaining on the sieve and that passing through the sieve determined the masticatory performance. | T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded | 
| change in patient's satisfaction | The evaluation will be by 100 mm Visual Analog Scale (VAS), for which higher scores indicate greater satisfaction, They will be asked to rate their level of comfort, ability to chew, stability, ability to speak, ease of cleaning their prostheses and their general satisfaction. | T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded | 
| change in oral health related quality of life | The evaluation will be by oral health impact profile of edentulous (Ohip-Edent) instrument, Patients will answer questions of ohip-edent which included 7 domains: functional limitation, physical pain, psychological discomfort, physical disability, Psychological disability, Social disability, Handicap. Responses will made on a five-grade Likert-type scale: 0=never ; 1=hardly ever ; 2=occasionally ; 3= fairly often ; 4= very often. disability, social disability and handicap | T1: before implantation; T2: 1 month after loaded; T3: 3 month after loaded; T4: 6 month after loaded; T5:12 month after loaded | 
| change in Peri-implant crestal alveolar bone loss | The evaluation will be by panoramic radiogram, Peri-implant vertical and horizontal alveolar bone loss will measure (in mm) at the mesial and distal surface of each implant. implant | T1: on same day of loaded; T2: 3 month after loaded; T3: 6 month after loaded; T4:12 month after loaded | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implant, overdenture, Immediate loading