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OpenTrials
Completed

NCT Number: NCT06376019

Occlusion and Disocclusion Time in Immediately Loaded Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants

complete denture wearers struggle to eat well with their dentures due to poor denture retention, stability, and occlusal disharmony. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Ain Shams University

Cairo, 11361, Egypt

About this study

The gold standard treatment for completely edentulous patients is a removable complete denture, which satisfies patients functional and aesthetic requirements at a low cost. However, the main problem associated with a complete denture is the instability of the complete removable denture, especially the mandibular one. Implant-assisted overdentures over two or three implants are used as a treatment option to increase stability, function, and retention of the denture at a reasonable cost. The immediate loading protocol allows the placement of temporary restoration on the day of implant placement surgery. Pierluigi Mondani pioneered intraoral welding in the early 1970s as an approach to load patients immediately with resin prosthesis and weld titanium implants to a titanium bar in their mouths. The technique of intraoral welding provides rigid splinting in cases of immediate implant loading. Occlusal loads and stability of occlusion are important to consider in the immediate loading of implants to avoid implant biomechanical failures, marginal bone loss, or even complete loss of osseointegration. Quantitative analyzers like t-scans, which are pressure-sensitive films, and virtual technology give a precise method of assessing the sequence of time and occlusal contact force magnitude by converting qualitative data into quantitative parameters. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • completely edentulous patients
  • non-smokers
  • good oral hygiene
  • motivated patients

Exclusion criteria

  • major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus
  • the need for extensive bone grafting in planned implant site
  • pregnancy
  • patients under bisphosphonate treatment
  • limited mouth-opening for executing the implant surgery.

Treatment and study plan

solitary Implant loading with ball attachment

Procedure

ball attachment will be attached to the dental implant on the day of implant placement

splinted Implant loading with intra oral welding

Procedure

Titanium bar will be welded to the dental implant on the day of implant placement

complete denture

Procedure

Mucosa supported conventional complete denture will be fabricated without supporting implants

Primary outcomes

  1. Assessment of occlusion/disocclusion time

    Time frame: 3 months

    occlusion/disocclusion time will be evaluated using a T scan device

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Evaluation of Occlusion and Disocclusion Time in Immediately Loaded Implant Supported Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2024
Registry last updated
Aug 7, 2025

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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