Influence of Acetal Resin Versus Nylon Elastic Cap on Crestal Bone Loss in Mandibular Implant-Supported Overdenture
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acetal Resin, nylon.
- Who it may be relevant to
- Registry conditions: Bone Loss, Pocket, Periodontal. Basic parameters: 40 years — 60 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Objective: To evaluate and compare the effect of two different attachment housing materials-Acetal Resin (Polyoxymethylene) versus conventional Nylon elastic caps-on marginal crestal bone loss around dental implants supporting a mandibular overdenture. It also evaluates peri-implant clinical tissue health by measuring pocket depth and the gingival bleeding index.
Detailed description
Study Design \& Timeline: A prospective, double-blind, randomized controlled clinical trial with a 1:1 allocation ratio. Clinical and radiographic outcomes will be evaluated at overdenture insertion (baseline), and at 6 and 12 months post-insertion.ethodology \& Analysis: Pre-operative bone volume will be assessed via Cone Beam CT (CBCT). Crestal bone loss will be measured using the long cone parallel radiographic technique , while pocket depth and gingival bleeding will be measured using a William's graduated probing device. Data will undergo normality testing to determine the use of parametric (Independent t-test, Repeated Measures ANOVA) or non-parametric (Mann-Whitney, Friedman) statistical analyse
Interventions
- Device Acetal Resin
overdenture supported by implants - Device nylon
overdenture supported by implants
Primary outcome measures
- Change in crestal bone levels [Time frame: one year]
Secondary outcome measures (1)
- pocket depth changes [Time frame: one year]
Eligibility criteria
Inclusion criteria
- Completely edentulous mandible.
- Sufficient bone height/width in mandibular residual ridges.
- Angles classification class I.
- Sufficient inter-arch distance
Exclusion criteria
- TMJ disorders.
- Diabetic
- Hypertensive
- Cancer patients.
- Smoker
- Osteoporosis.
- Immunosuppressive disease
- Any disease affecting bone/implant stability.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07666763 · FUE