Treatment Outcome of Short Implant Assisted Mandibular Overdenture

Study Overview
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Brief Summary
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This study evaluates the use of short dental implants to support mandibular overdenture together with the use of laser therapy for treatment of patients with atrophic ridges. All participants will receive laser therapy; half of participants will receive two short implants and the other half will receive four short implants.

Detailed Description
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The conventional solution to complete edentulism is the use of complete removable dentures. One negative effect of edentulism is resorption of the edentulous ridge over time. Construction of a successful mandibular complete denture for patients with advanced mandibular ridge resorption is often difficult and on some occasions virtually impossible. It has been proved that when implants are placed, bone gets stimulated resulting in minimal bone loss. But anatomic limitations to implant placement have been observed in atrophic ridges, so short implants introduced as a recent alternative to aggressive surgical procedures proposed to compensate for tissue deficiency. Also, Low Level Laser Therapy (LLLT) has proven success in improving implant stability which is very crucial in short implants. Thus, the purpose of this study is to evaluate and compare the treatment outcome of mandibular overdenture assisted by two short implants versus that assisted by four short implants in combination with LLLT.

Official Title
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Treatment Outcome of Short Implant Assisted Mandibular Overdenture in Combination With Low Level Laser Therapy

Conditions
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Atrophy of Edentulous Mandibular Alveolar Ridge

Intervention / Treatment
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* Combination Product: Two short implants and 2 minutes LLLT
* Combination Product: Two short implants and 4 minutes LLLT
* Combination Product: Four short implants and 2 minutes LLLT
* Combination Product: Four short implants and 4 minutes LLLT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completely edentulous patients. Patients with mandibular resorbed edentulous ridge. Medically fit patients with no systemic conditions. Class I ridge relation. Adequate zone of keratinized mucosa. Exclusion Criteria: Metabolic bone disease or unstable systemic condition. Heavy smokers. A history of radiotherapy in the head and neck region. Physical or mental disability. Temporomandibular and neuromuscular disorders.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Two short implants and 2 minutes LLLT<br>Patients receiving 2 short dental implants assisted mandibular over-denture and Low level laser therapy (LLLT) for 2 minutes . | Combination Product: Two short implants and 2 minutes LLLT<br>* Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 2 minutes.<br>|
| Active Comparator: Two short implants and 4 minutes LLLT<br>Patients receiving 2 short dental implants assisted mandibular over-denture and LLLT for 2 minutes . | Combination Product: Two short implants and 4 minutes LLLT<br>* Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 4 minutes.<br>|
| Active Comparator: Four short implants and 2 minutes LLLT<br>Patients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 2 minutes . | Combination Product: Four short implants and 2 minutes LLLT<br>* Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 2 minutes.<br>|
| Active Comparator: Four short implants and 4 minutes LLLT<br>Patients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 4 minutes . | Combination Product: Four short implants and 4 minutes LLLT<br>* Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 4 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of changes in implant stability (Implant Stability Quotient). | Implant stability can be defined as the absence of clinical mobility. It will be assessed at the time of implant placement (baseline) ,then six months and twelve months later, by the resonance frequency analysis using Osstel devise which measure implant oscillation frequency on the bone;Implant Stability Quotient (ISQ) . | Baseline, 6 months &12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-implant marginal bone changes. | Radiographic assessment of bone level changes around each implant will be performed to detect peri-implant crestal bone changes using standardised digital periapical x-ray. It will be assessed at the time of implant placement, six months and twelve months later. | Baseline, 6 months &12 months. | 
| Assessment of changes in peri-implant probing depth . | Peri-implant probing depth is the distance between the gingival margin and the most apically probeable portion, in millimetres. It will be measured at four sites of each implant (mesially, labially, distally, lingually) by using a graduated periodontal probe which will be held parallel to the long axis of the implant and introduced to the peri-implant sulcus till there is slight resistance. The mean record for each implant will be calculated. It will be evaluated at time of definitive prosthesis insertion then, six months and twelve months after implant placement. | Baseline, 6 months &12 months. | 
| Assessment of changes in modified gingival index | To qualify the degree of peri-implant inflammation, the modified gingival index will be used. It will be measured at four sites around each implant (mesially, labially, distally, lingually) and the mean record for each implant will be calculated. It will be evaluated at time of definitive prosthesis insertion, then six months and twelve months after implant placement. | Baseline, 6 months &12 months. |