Patient Satisfaction and Crestal Bone Changes Around One-piece Zirconia(Zr) and Titanium(Ti) in Implant-Retained Mandibular Overdenture

Not Applicable

Recruiting

• Conditions: Complete Edentulism

• Registration Number: NCT06643975
• Lead Sponsor: Ain Shams University

Brief Summary

This interventional randomized clinical trial study is conducted to assess patient satisfaction and crestal bone changes around one-piece Zr and Ti Implants in mandibular implant-retained overdenture in completely edentulous male patients in the age group between (50-60)years old to know if there will be a significant difference between the two types of dental implants through 12 months after the definitive prosthetic loading

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-15
• Status Verified: 2024-10
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-14
• Study First Posted: 2024-10-16
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-09-15
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Male patients
• The age range of 50 to 60 years old (average of 55).
• moderately developed mandibular residual ridges, covered with healthy mucosa, firmly attached to the underling bone and with average mucosal thickness (2-3) mm.
• At least 12 mm of vertical bone height in the mandible allowing for placement of a 10 mm implant (2 mm safety distance to inferior alveolar nerve).
• Patients were selected with Angle class-I maxillomandibular relationship with sufficient inter-arch space (13-15mm

Exclusion Criteria

• Heavy smokers of more than 10 cigarettes a day
• Poor oral hygiene.
• Patients with temporomandibular joint disorders(TMD),
• Patients suffered of xerostomia,
• Patients exhibited Para-functional habits, or recent extractions were excluded.
• Patients with systemic diseases that might affect bone quality or quantity, or retard healing of the surgical wounds were excluded.
• Patients receiving intravenous forms of bisphosphonates.
• Patients who have had radiation therapy to the head and neck region.
• Patients with existing implants in the jaws
• Patients with previous bone grafting in either the maxillary or mandibular jaws.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Crestal bone changes	12 months	Measuring the amount of marginal(crestal) bone changes either loss or gain around the dental implants using the cone beam computed tomography(CBCT) in millimeter scales about the original marginal bone height measured at the time of the visit of final (definitive) prosthetic loading.; The positive(+ve) values mean an increase (gain) in the marginal bone height around the implants, the more the +ve value, the more the gain in the bone height which is the better outcome, while the negative (-ve) values mean decrease (loss) in the marginal bone height around the implants, the more the -ve value, the more loss in the bone height, which is the worse outcome.

Secondary Outcome Measures

Name	Time	Method
Patients Satisfaction	12 months	measuring the degree of patient satisfaction using a Patient's Denture Assessment (PDA) questionnaire, via a Likert scale which uses a 5-point system from 1 to 5, All items are scored as follows: unsatisfactory =1 hardly satisfactory =2 moderately satisfactory=3 very satisfactory=4 excellent satisfaction=5 The greater (higher) the score, the more patient satisfaction, which is the better outcome, while the weaker (lower) the score, the less is patient satisfaction, which is the worse outcome.

Trial Locations

Locations (1)

Faculty of Dentistry, Ain Shams University; 🇪🇬 Cairo, Egypt