EVALUATION OF TWO DIFFERENT ATTACHMENT SYSTEMS IN MANDIBULAR OVERDENTURES RETAINED WITH TWO INCLINED IMPLANTS

Not Applicable

Recruiting

• Conditions: Inclined Implants
• Interventions: Other: Novaloc Attachment; Other: Locator Attachment

• Registration Number: NCT05695612
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-10
• Status Verified: 2023-01
• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-13
• Last Update Submitted: 2023-01-13
• Study First Posted: 2023-01-25
• Last Update Posted: 2023-01-25
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Patients should be completely edentulous.
• Patients should have enough bone for the placement of implants at least 3.5 mm in diameter and 10.0 mm in length.
• Patients should be co-operative and have adequate dexterity for placement and removal of the implant -retained overdenture.
• The inter-ridge space should be sufficient to place the endosseous implants and the superstructures

Exclusion Criteria

• Patients with any systematic disease that could complicate the surgical phase or affect osseointegration as osteoporosis and uncontrolled diabetes mellitus.
• Patients with active oral infections.
• Patients with history of radiotherapy in head and neck region.
• Patients with poor oral hygiene.
• Patients with restricted mouth openings ≤ 40mm, functional limitations, or temporo-mandibular disorders.
• Heavy smokers (more than 10 cigarette / day).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novaloc Attachment	Novaloc Attachment	-
Locator attachment	Locator Attachment	-

Primary Outcome Measures

Name	Time	Method
Peri-implant Probing Depth (PD)	up to 12 months	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.
Modified Sulcus Bleeding Index (BI)	up to 12 months	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
Modified gingival index	up to 12 months	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.
Alveolar bone level	up to 12 months	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.
Implant stability	up to 12 months	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt