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NCT Number: NCT06643975

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

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

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Key information

Conditions

Complete Edentulism

Age range

50 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

One-piece zirconia dental implants

Other

One-piece zirconia dental implants with zirconia ball attachments, these implants are metal free made of oxide ceramics with cutting-edge Selective laser melting(SLM) surface treatment technology

Other names: Z-SYSTEMS, ceramic implants

One-piece titanium dental implants

Other

One-piece Titanium dental implants with titanium ball attachments, these implants are gold standard compatible implants

Primary outcomes

  1. Crestal bone changes

    Time frame: 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 outcomes

  1. Patients Satisfaction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammad Irakky, masters

CONTACT

[email protected]

00201111232777

Omnia M. Refai, Phd

CONTACT

[email protected]

00201202420046

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Assessment of Patient Satisfaction and Crestal Bone Changes Around One-piece Zirconia and Titanium Implants in Mandibular Implant-Retained Overdenture: A Randomized Clinical Trial

Acronym: (Zr) - (Ti)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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