An interventional study of OT-Equator Attachment and Novaloc Attachment in Edentulous Alveolar Ridge In Mandible, Complete Edentulism and Dental Implant, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 60 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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."
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.
Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
On the 2nd Stage, implants will be loaded with OT-Equator Attachment to retain overdenture
Procedure: OT-Equator Attachment
On the 2nd Stage, implants will be loaded with Novaloc Attachment to retain overdenture
Procedure: Novaloc Attachment
Two implants will be restored using OT attachment systems, with the mandibular denture retained over these attachments through corresponding metal housing
Two implants will be restored using Novaloc attachment systems, with the mandibular denture retained over these attachments through corresponding metal housing
Retention
it will be measured using digital force gauge
Time frame: It will be measured at denture insertion, 6 months and 12 months
The Oral Health Impact Profile (OHIP) questionnaire
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.
Time frame: It will be measured at denture insertion, 6 months and 12 months
Patient Satisfaction
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
Time frame: it will be measured at denture insertion, 6 month, and 12 month later.
Plan to share: Yes — Study Protocol and Clinical Study Report
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Al-Azhar University