NCT06139003

Brief Summary

The aim of this study is to evaluate of two different construction techniques (digital and conventional techniques) for two implant retained complete mandibular overdenture regarding: 1\. Digital occlusion stability detection: evaluated by using OccluSense. Evaluation was done in the following evaluation period: T0: Immediately after over denture insertion. T6: 6 months after over denture insertion. T12: 12 months after over denture insertion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

October 30, 2023

Last Update Submit

November 16, 2023

Conditions

Occlusal Wear of Teeth

Outcome Measures

Primary Outcomes (2)

  • occlusal stability

    Using occlusense device to determine distribution of occlusal forces over anterior and posterior areas, right and left side through chart representing areas of occlusal contact

    at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)

  • Occlusal analysis

    Group I and group II will be subjected to test by utilization of the Digital Occlusal Analyzer System (OccluSense) then amount of occlusal force over each unit presented in percentage

    at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)

Study Arms (2)

3d Printed implant overdenture

EXPERIMENTAL

patients will receive maxillary CD and mandibular 2-implant retained overdenture over locator attachment constructed by digital technique.

Device: 3d Printed implant

Conventionally constructed implant overdenture

EXPERIMENTAL

patients will receive maxillary CD and mandibular 2-implant retained overdenture over locator attachment constructed by conventional technique.

Device: Conventionally constructed implant

Interventions

3d Printed implantDEVICE

Occlusal stability was evaluated using occlusense device by charting amount and distribution of force over dental arch in percentage

3d Printed implant overdenture
Conventionally constructed implantDEVICE

Occlusal stability was evaluated using occlusense device by charting amount and distribution of force over dental arch in percentage

Conventionally constructed implant overdenture

Eligibility Criteria

Age45 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis.
  • Completely edentulous jaws for at least 1 year.
  • The angle's class I maxillomandibular relationship and have upper and lower completely edentulous arches.
  • Residual alveolar ridges covered with healthy firm mucosa.
  • All included patients' sufficient available length and width of mandibular bone to accommodate conventional implant. (At least 5 mm buccolingual width and 12 mm vertical height of bone).

You may not qualify if:

  • Patients with systemic diseases that contraindicate implant placement such as hematologic diseases
  • metabolic diseases related to bone resorption such as uncontrolled diabetics or osteoporosis will be also excluded
  • History of para-functional habits (Bruxism, clenching), smoking and alcoholism.
  • History of radiation therapy in the head and neck region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University, Faculty of dentistry

Al Mansurah, Egypt

Location

Related Publications (1)

  • Ali AEA, Habib A, Shady M. Digital versus conventional techniques for construction of mandibular implant retained overdenture. BMC Oral Health. 2025 May 5;25(1):686. doi: 10.1186/s12903-025-05918-2.

    PMID: 40325470DERIVED

Study Officials

  • Mohamed Shady, MD

    Mansoura University Faculty of Dentistry, Prosthodontics department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 18, 2023

Study Start

August 20, 2022

Primary Completion

September 20, 2022

Study Completion

August 20, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)