Clinical Evaluation of Implant Overdentures Fabricated Using 3D -Printing Technology Versus Conventional Fabrication Technique: A Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- . OHRQoL (oral health related quality of life)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Metabolic disorders affecting osseointegration such as hepatic disorders
- •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
Outcomes
Primary Outcomes
. OHRQoL (oral health related quality of life)
Time Frame: 12 months
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.
Secondary Outcomes
- Overdentures' retention(12 months)
Investigators
Dina ElAwady
lecturer of Prosthodontics (principal investigator)
October University for Modern Sciences and Arts