Clinical trial NCT06678945: Using Two Different Attachments in Mandibular Implant Overdenture Cases in Order to Retention and Patient Satisfaction
Official title: Comparing Two Different Attachments Retaining Mandibular Implant Overdenture Regarding Retention and Patient Satisfaction (Randomized Clinical Trail)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Edentulous Alveolar Ridge
Complete Edentulism
Dental Implant
Attachments
Implant Supported Overdenture
Edentulous Mouth
Edentulous Jaw
Keywords: Dental Implants
Completely edentulous patients
Edentulous Ridge
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Goal of the clinical trail is to evaluate the efficacy of Bar- OT Equator attachment on retention and patient satisfaction in comparison to the standard technique using Bar- clip attachment.

Patients will visit the clinic after the surgery and after the attachment insertion for check ups and during the follow up periods ( at denture insertion, 3 months and 6 months)

Detailed description: 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 divided into two equal groups; Group I will be retained by Bar-Clip attachment, while Group II will be retained by Bar- OT Equator attachment. Both groups will be functionally loaded after three months of insertion.

Retention of lower denture will be measured using digital force gauge and Patient satisfaction was evaluated with a standard 5-point Liker scale questionnaire. All parameters will be measured at denture insertion, 3 month, and 6 month later.

Eligibility criteria: Inclusion Criteria:

* All patients age must range from 60- 70 years old.
* 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.
* Patients should be free from any metabolic or bone disorder that contraindicate implant installation.
* 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

Primary outcomes:
measure: Retention
timeFrame: it will be measured at denture insertion, 3 month, and 6 month later
Secondary outcomes:
measure: Patient satisfaction
timeFrame: it will be measured at denture insertion, 3 month, and 6 month later.
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
state: Al Saraya, Old Cairo
Study officials:
References: