NCT06946693

Brief Summary

Patient attending the Outdoor Patient Department of the Department of Prosthodontics at Post Graduate Institute of Dental Sciences, Rohtak will be screened. The screening will include history, consent taking and clinical examination of the partially edentulous patients. Patients will be selected according to the inclusion and exclusion criteria. Single stage endosseous implants will be placed. Provisional restorations fabricated by conventional technique, milling, and 3D printing will constitute three groups, followed by evaluation of color stability and surface roughness after intraoral use.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
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 Progress66%
Apr 2025Jan 2027

Study Start

First participant enrolled

April 18, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 19, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2027

Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

April 19, 2025

Last Update Submit

April 19, 2025

Conditions

Keywords

PROVISIONAL RESTORATIONS

Outcome Measures

Primary Outcomes (2)

  • Surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.

    Surface roughness of provisional restorations will be measured using profilometer

    1 year 6 months

  • Color stability of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.

    Color stability of provisional restorations will be measured using spectrophotometer

    1 year 6 months

Study Arms (3)

To evaluate the surface roughness and color stability of Conventional provisional restorations

ACTIVE COMPARATOR
Procedure: To evaluate the color stability and surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing in mandibular posterior region.

To evaluate the surface roughness and color stability of 3D Printed provisional restorations

ACTIVE COMPARATOR
Procedure: To evaluate the color stability and surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing in mandibular posterior region.

To evaluate the surface roughness and color stability of Milled provisional restorations

ACTIVE COMPARATOR
Procedure: To evaluate the color stability and surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing in mandibular posterior region.

Interventions

Subjects with single stage implant placement and early non-functional loading with implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.

To evaluate the surface roughness and color stability of 3D Printed provisional restorationsTo evaluate the surface roughness and color stability of Conventional provisional restorationsTo evaluate the surface roughness and color stability of Milled provisional restorations

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Subjects consented to participate in the study. 2. Subjects with maintainable oral hygiene. 3. Subjects with adequate edentulous space at the prospective implant site. 4. Subjects with availability of adequate quantity and quality of bone.

You may not qualify if:

  • Subject with presence of infection around proposed site of implant placement.
  • Subjects with any condition that would interfere with the soft tissue and bone healing.
  • Subjects in which surgical procedure is contraindicated for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Interventions

Printing, Three-Dimensional

Intervention Hierarchy (Ancestors)

TechnologyTechnology, Industry, and Agriculture

Study Officials

  • NALIKA MOUNGKHOM, BACHELOR OF DENTAL SURGERY

    POST GRADUATE INSTITUTE OF DENTAL SCIENCES ROHTAK, HARYANA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MANU RATHEE, MASTER OF DENTAL SURGERY

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Comparative assessment of the Color Stability and Surface Roughness of Implant-Supported Provisional Restorations Fabricated by Conventional Technique, Milling and 3D Printing: A Randomized Controlled Clinical Trial

Study Record Dates

First Submitted

April 19, 2025

First Posted

April 27, 2025

Study Start

April 18, 2025

Primary Completion (Estimated)

August 18, 2026

Study Completion (Estimated)

January 18, 2027

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations