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

A

Ain Shams University

Status

Not yet enrolling

Conditions

Edentulous Jaw

Treatments

Procedure: solitary Implant loading with ball attachment
Procedure: complete denture
Procedure: splinted Implant loading with intra oral welding

Study type

Interventional

Funder types

Other

Identifiers

NCT06376019
FDASU-RecID11352

Details and patient eligibility

About

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.

Full description

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.

Enrollment

27 estimated patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

27 participants in 3 patient groups, including a placebo group

group CD (conventional complete denture group)
Placebo Comparator group
Description:
patients will receive a conventional complete denture with no implant placement
Treatment:
Procedure: complete denture
group IB (implant-supported overdenture with ball attachment)
Active Comparator group
Description:
patients will receive an implant-supported overdenture with ball attachment. The overdenture will be relined by a soft liner.
Treatment:
Procedure: solitary Implant loading with ball attachment
group II (implant-supported overdenture with an intraoral welded bar)
Active Comparator group
Description:
patients will receive an implant-supported overdenture with an intraoral welded bar. The overdenture will be relined by a soft liner.
Treatment:
Procedure: splinted Implant loading with intra oral welding

Trial contacts and locations

1

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Central trial contact

Ahmed MA Mohamed, BDS MSc,MD

Data sourced from clinicaltrials.gov

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