The aim of the study is to evaluate clinically and radiographically the Novaloc and Locator attachment systems in mandibular overdentures retained with two inclined implants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
Each patient will receive two inclined implants placed in the mandibular canine region bilaterally using the flapless surgical technique. Patients will receive mandibular overdentures with Novaloc attachments. The proper Novaloc abutments will be selected and screwed on the implants according to the prosthetic platform and the tissue height. The metal housings will be connected to the existing mandibular overdenture by pick-up technique.
Each patient will receive two inclined implants placed in the mandibular canine region bilaterally using the flapless surgical technique. Patients will receive mandibular overdentures with Locator attachments. The proper Locator abutments will be selected and screwed on the implants according to the prosthetic platform and the tissue height. The metal housings will be connected to the existing mandibular overdenture by pick-up technique.
Faculty of Dentistry, Alexandria University
Alexandria, Egypt
RECRUITINGPeri-implant Probing Depth (PD)
The distance from the gingival margin till the point of least resistance will be measured using a graduated plastic autoclavable periodontal probe. The probe will be held parallel to the long axis of the implant and introduced with light force to the peri-implant sulcus. Measurements will be made at 6 sites around each implant; mesiobuccal, mid-buccal, disto-buccal, mesio-palatal, mid-palatal and disto-palatal. Probing depth of 1 mm or less will be recorded as 1 mm, and those exceeding 1 mm, but less than 2 mm, will be recorded as 2 mm, and so on. The mean for each implant will be calculated.
Time frame: up to 12 months
Modified Sulcus Bleeding Index (BI)
This will be measured using a graduated plastic autoclavable periodontal probe. The probe will be held parallel to the long axis of the implant and introduced with light force to the peri-implant sulcus. A score of 0-3 will be assigned to each labial and palatal surface of the implant then the average for each implant will be calculated according to the following criteria: Score 0: No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant. Score 1: Isolated bleeding spots visible. Score 2: Blood forms a confluent red line on margin. Score 3: Heavy or profuse bleeding
Time frame: up to 12 months
Modified gingival index
The peri-implant mucosal tissues will be assessed according to Lobene and Weatherford as follows: 0: Absence of inflammation, normal gingiva. 1. Mild inflammation, slight color change, little change in texture of any portion of, but not entire, marginal, or papillary gingival unit (localized). 2. Mild inflammation, slight color change, little change in texture involving the entire or papillary gingival unit (generalized).. 3. Moderate inflammation, redness, and edema. 4. Severe inflammation, marked redness, edema, ulceration, and spontaneous bleeding It will be measured at 4 sites around each implant (mesially, distally, labially/ buccaly, lingually) then, the mean record will be calculated for each implant. Indices of the two implants will be added to each other, and then divided by 2 to get the mean modified gingival index for each case.
Time frame: up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Alveolar bone level
The level of alveolar bone around each implant will be assessed using CBCT(3D Accuitomo 170, 90 kVp, 5 mA, 30.8 s, 0.08 mm isotropic voxel size, J Morita, Kyoto, Japan) and the field of view will be the lower anterior sextant. The vertical bone change (distance from the implant platform to the first bone-to-implant contact, in mm) around each implant will be assessed at the buccal, lingual, mesial and distal aspects then the mean will be calculated.
Time frame: up to 12 months
Implant stability
Magnetic Resonance Frequency Analyser will be used to measure the implant stability quotient (ISQ). The instrument measures the resonance frequency through the transducer attached to a implant fixture and display the result ISQ value on a scale of 1 to 100 with higher values indicating higher stability. The measurements will be made three times and the mean will be calculated.
Time frame: up to 12 months