NCT04569929

Brief Summary

A randomized clinical trial (RCT) was designed. Fourteen completely edentulous participants were randomly allocated into two equal groups. All participants received two implants in the inter-foraminal area with ball attachments. Participants in the control group were rehabilitated with conventionally manufactured Polymethyl Methacrylate (PMMA) maxillary complete denture and mandibular implant overdentures while participants in intervention group received digital light processed (DLP)-printed photo-polymerizable PMMA Nextdent maxillary complete denture and mandibular implant overdentures. Follow-up appointments were scheduled at 3,6, and 12 months where data of Oral Health Impact Profile 19(OHIPEDENT19) was used to assess the OHRQoL (oral health related quality of life). In addition, denture retention was measured using digital force gauge device. Data were collected and statistically analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

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

January 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

1.4 years

First QC Date

September 23, 2020

Last Update Submit

December 14, 2020

Conditions

Edentulous Mouth

Outcome Measures

Primary Outcomes (1)

  • . OHRQoL (oral health related quality of life)

    Oral Health Impact Profile 19 (OHIPEDENT19) was used to assess the OHRQoL (oral health related quality of life). The questionnaire was translated to Arabic and validated (S2).24 The profile consisted of 19 questions each with score 0 to 4 (impaired) on Likert scale; accordingly, for each patient the minimum score was 0 and maximum score was 76.

    12 months

Secondary Outcomes (1)

  • Overdentures' retention

    12 months

Study Arms (2)

control

ACTIVE COMPARATOR

conventionally manufactured Polymethyl Methacrylate (PMMA) mandibular implant overdentures

Other: (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture

intervention

EXPERIMENTAL

digital light processed (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdentures

Other: (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture

Interventions

(DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdentureOTHER

The bite registration records with their corresponding master casts were digitalized using an extra oral desktop 3D scanner (3shape D850) and then stored as standard triangulation language (STL) files (Figure 1). The STL files were then imported to Dental system PREMIUM3 design software (3Shape Dental System 2018) for model analysis, surveying and blocking out, designing full permanent denture bases, and for virtual teeth set-up following the recorded inter-arch space

controlintervention

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • completely edentulous
  • ranging in age from 50 to 65 years
  • Angle's class I skeletal relationship, normal facial symmetry.
  • Adequate quantity of bone (class IV -VI ) and quality (classes 1 - 3 ) in the mandibular inter-foraminal area to accommodate standard implants of at least 11 mm length and 3.7 mm diameter
  • appropriate inter-arch space of at least 15 mm (class I ) to accept all types of tested dentures

You may not qualify if:

  • osteoporosis and diabetes mellitus.
  • Temporomandibular disorders, anticoagulant therapy or bleeding disorders
  • sharp mandibular residual ridge or flabby tissues
  • neuromuscular disorders, and class II and III Angle's classification skeletal relationship
  • Smokers and patients on chemotherapy or radiotherapy or suffering from psychiatric conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Msa Uni

Giza, Egypt

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Dina Elawady, PHD

    MSA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Prosthodontics (principal investigator)

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 30, 2020

Study Start

January 1, 2019

Primary Completion

June 5, 2020

Study Completion

August 10, 2020

Last Updated

December 16, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)