Attachment, Complete Edentulism, Dental Implant, Edentulous Alveolar Ridge In Mandible, Implant Retained Overdenture
Conditions
Keywords
Dental Implants, Attachments, Edentulous Ridge
Brief summary
This randomized clinical trial investigates the effect of two different attachment systems-Equator and Novaloc-on the retention, patient satisfaction, and oral health-related quality of life of mandibular implant overdentures. Completely edentulous patients often experience reduced denture stability, compromised chewing ability, and diminished oral function with conventional complete dentures. Implant-retained overdentures have been shown to improve retention, stability, and overall patient satisfaction. Equator attachments offer a small, resilient, and self-aligning system with variable retention levels, while Novaloc attachments feature innovative PEEK caps and a diamond-like carbon coating designed to reduce wear and maintain long-term retention. This study aims to determine whether one attachment system provides superior functional outcomes and patient-centered benefits, thereby guiding clinicians in optimizing overdenture therapy for edentulous patients."
Detailed description
All 26 patients will receive upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region. Patients will be randomly divided into two equal groups; Group I will be retained by Novaloc attachment. While, Group II will be retained by Equator attachment. Implants will be functionally loaded after three months of insertion. Retention of lower denture will be measured using digital force gauge, Oral health quality of life will be measured by verbal The Oral Health Impact Profile (OHIP) questionnaire. Patient satisfaction was evaluated with a standard 5-point Liker scale questionnaire. All parameters will be measured at denture insertion, 6 month, and 12 month later.
Interventions
PROCEDUREOT-Equator Attachment
Two implants will be restored using OT attachment systems, with the mandibular denture retained over these attachments through corresponding metal housing
PROCEDURENovaloc Attachment
Two implants will be restored using Novaloc attachment systems, with the mandibular denture retained over these attachments through corresponding metal housing
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. All patients' ages must range from 60-70 years old. 2. All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge. 3. Patients should be free from any metabolic or bone disorder that contraindicate implant installation. 4. All patients must have sufficient inter arch space
Exclusion criteria
1. Patients with oral or systemic diseases. 2. Patients with xerostomia or excessive salivation. 3. Patients with parafunctional habits (bruxism or clenching). 4. Heavy smoker or alcoholic patients. 5. Patients with history of temporo-mandibular dysfunction. 6. Patients with brain disorders or psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | It will be measured at denture insertion, 6 months and 12 months | it will be measured using digital force gauge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Oral Health Impact Profile (OHIP) questionnaire | It will be measured at denture insertion, 6 months and 12 months | It is one of the most technically sophisticated instruments used for assessment of OHRQoL. The OHIP was developed and validated by Slade and Spencer and several versions of the tool have been developed thereafter. Among the available short versions, the OHIP-EDENT has been deemed the most appropriate tool for the edentulous patients, as it presented a set of specific questions. The tool detects the impact of oral health on the quality of life of patients with implant supported overdenture prosthesis, before and after they have received them. |
| Patient Satisfaction | it will be measured at denture insertion, 6 month, and 12 month later. | Patient satisfaction was evaluated with a standard 5-point Likert scale questionnaire, which included subjective parameters such as initial adaptability, post insertion problems, aesthetics, masticatory ability, speech, retention. Patients were asked to respond to question given in the questionnaire |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORNoha T Alloush, Lecturer
Misr International University
Outcome results
None listed