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OpenTrials
Completed

NCT Number: NCT06720389

Effect of Two Different Digital Construction Techniques of Implant-assisted Overdentures

twenty patients received mandibular overdenture constructed by different construction techniques were classified equally and randomly into two groups peri implant bone loss was assessed by CBCT at baseline (T0), at1 year(T1), at 3 years(T3) and posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

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Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Egypt

About this study

twenty patients received mandibular overdenture constructed by different construction techniques were classified equally and randomly into two groups (n = 10 per group): Group A: received milled mandibular overdenture opposed by maxillary complete denture. Group B: received 3D-printed mandibular overdenture opposed by maxillary acrylic complete denture. peri implant bone loss was assessed by CBCT at baseline (T0), at1 year(T1), at 3 years(T3) and posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All patient wearing maxillary conventional denture.
  • All patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago.
  • A Cone Beam Computed Tomography (CBCT) done to verify the accurate position and success of the inserted implant.
  • They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
  • At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna). This was detected by a tentative jaw relation.
  • All patients are of angel's class I maxillo-mandibular relationships.

Exclusion criteria

  • Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
  • Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
  • Long term immunosuppress and corticosteroid drug therapy.
  • Patient with abnormal habits as clenching and bruxism.
  • Smoking patient.
  • Uncooperative patients.
  • Neuromuscular diseases.
  • Patient with problems in TMJ.

Treatment and study plan

peri implant bone loss was assessed by CBCT

Radiation

using CBCT, vertical bone loss (VBL) was measured at baseline (T0), at1 year(T1), at 3 years(T3)

posterior ridge resorption was assessed by CBCT

Other

posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

Primary outcomes

  1. peri implant bone loss

    Time frame: at baseline (T0), at1 year(T1), at 3 years(T3)

    peri implant bone loss was assessed by CBCT

  2. posterior ridge resorption

    Time frame: at baseline (T0), at 1 year( T1), at 3 years (T3).

    posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Effect of Two Different Digital Construction Techniques of Implant-assisted Overdentures: a 3-year Prospective Radiographic Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2024
Registry last updated
Dec 18, 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.