Immediate vs Delayed Loading of Two Implants Supporting a Mandibular Over Denture

Study Overview
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Brief Summary
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Edentulous patients have to wait after extractions and again after surgical implant placement for healing to occur before the implants can be restored and patients can go back to normal function. This delay in loading of implants can be handicapping for the patient, esthetically and functionally. Hence this project was undertaken with the purpose of reducing this wait period and achieving early rehabilitation in these patients. The aim of the project is to compare immediate loading versus delayed loading of implant supported mandibular dentures.

Official Title
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Immediate vs Delayed Loading of Two Implants Supporting a Locator Retained Mandibular Overdenture - A Randomized Controlled Study

Conditions
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Implant Survival Using Immediate Loading Protocol

Intervention / Treatment
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* Procedure: dental implant placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females at least >=21y of age Provision of informed consent Totally edentulous arch requiring or wearing mandibular complete denture Tooth in implant sites must have been extracted at least 4 months before the implant placement. Adequate amount of bone support to insert a 8mm in length and 4mm in diameter implant without encroaching on vital structures. The amount of bone available should be such that after implant placement there should be minimum of 1mm lingual and buccal bone Implant insertion torque >=20Ncm No need for bone augmentation procedures Exclusion Criteria: Conditions or circumstances as evaluated by the investigator, which would prevent completion of study participation. Conditions requiring chronic routine use of antibiotics or requiring prolonged use of steroids. History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection Use of investigational drugs or devices within 30 days of study period, Alcoholism or drug abuse and heavy smokers > 10 cigarettes a day. Local factors such as untreated periodontitis, erosive lichen planus, local irradiation history, osseous lesion, unhealed extraction socket, intraoral infection, lack of primary stability inadequate oral hygiene Simultaneous participation in another clinical study

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate implant loading<br>The test group had implant immediately loaded by means of a implant supported mandibular denture connected with locator abutment. | Procedure: dental implant placement<br> <br> |
| Active Comparator: Delayed implant loading group<br>The control group had implant loaded after 3 months of submerged healing by means of a implant supported mandibular denture connected with locator abutment. | Procedure: dental implant placement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic bone level change around the implants |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immediate loading of dental implant, implant supported over denture