NCT06080815

Brief Summary

This within patient study will be conducted to compare between two different construction techniques (CAD-CAM Milled and Conventional techniques) of 4-implant-assisted complete mandibular overdenture bases regarding the digital occlusion force balance analysis using the OccluSense

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
Last Updated

October 12, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

October 8, 2023

Last Update Submit

October 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • digital occlusal analysis

    occlusion was analyzed by occlusense device

    6 months

Study Arms (2)

Group I: patients receive maxillary complete denture opposed to conventional mandibular overdenture

ACTIVE COMPARATOR
Device: CAD/CAM Complete denture

Group II: patients receive maxillary complete denture opposed CAD/CAM overdenture

ACTIVE COMPARATOR
Device: CAD/CAM Complete denture

Interventions

four implant-supported CAD/CAM complete overdenture

Group I: patients receive maxillary complete denture opposed to conventional mandibular overdentureGroup II: patients receive maxillary complete denture opposed CAD/CAM overdenture

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Free from any systemic diseases that contraindicate dental implantation. 2. Angel's class I maxillo- mandibular relation. 3. Available inter-arch space and sufficient restorative space. 4. Nonsmokers, non-alcoholics. 5. Complaints from their conventional denture

You may not qualify if:

  • diabetic and heavy smoker patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

  • Abdelghany AA, Fouad MM, Emera RMK, Askar O, Yaseen AAM. Impact of mandibular 4-implant overdenture base construction techniques on assessment of occlusion with digital occlusion analysis system (clinical crossover study). BMC Oral Health. 2025 May 30;25(1):853. doi: 10.1186/s12903-025-06228-3.

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: According to the construction technique for the maxillary complete denture and mandibular overdentures, the patients will be classified randomly and equally into two groups. Group I: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with conventional method. Group II: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with CAD/CAM milling.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2023

First Posted

October 12, 2023

Study Start

May 10, 2022

Primary Completion

December 15, 2022

Study Completion

March 7, 2023

Last Updated

October 12, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations