NCT07666763

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Jul 2026

Status
not yet recruiting

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 Progress8%
Jul 2026Aug 2027

First Submitted

Initial submission to the registry

June 7, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

11 months

First QC Date

June 7, 2026

Last Update Submit

June 21, 2026

Conditions

Bone LossPocket, Periodontal

Outcome Measures

Primary Outcomes (1)

  • Change in crestal bone levels

    mm

    one year

Secondary Outcomes (1)

  • pocket depth changes

    one year

Study Arms (2)

intervention

EXPERIMENTAL

acetal

Device: Acetal Resin

control

ACTIVE COMPARATOR

Nylon Elastic

Device: nylon

Interventions

Acetal ResinDEVICE

overdenture supported by implants

intervention
nylonDEVICE

overdenture supported by implants

control

Eligibility Criteria

Age40 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsto avoid hormonal imbalance
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Completely edentulous mandible.
  • Sufficient bone height/width in mandibular residual ridges.
  • Angles classification class I.
  • Sufficient inter-arch distance

You may not qualify if:

  • TMJ disorders.
  • Diabetic
  • Hypertensive
  • Cancer patients.
  • Smoker
  • Osteoporosis.
  • Immunosuppressive disease
  • Any disease affecting bone/implant stability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone Diseases, MetabolicPeriodontal Pocket

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgrad stuident

Study Record Dates

First Submitted

June 7, 2026

First Posted

June 24, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

1\. Chronological Timeline and FrameworkTrial Duration: The active comparative clinical trial is designed to span a duration of one year. Measurement Intervals: Data collection and patient evaluation are scheduled at three distinct time points: at overdenture insertion (baseline), at 6 months, and at 12 months post-insertion