NCT06205459

Brief Summary

this clinical trial is conducted to compare between deep marginal acquistion by the means of thermacut bur Vs. functional crown lengthening in exposing deep subgingival interproximal cervical lesions

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2020

Completed
3.7 years until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

February 2, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

April 26, 2020

Last Update Submit

January 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction: visual analogue scale

    using visual analogue scale

    immediate post operative, 3 month, 6 month and 1 year

Secondary Outcomes (1)

  • Pocket depth and biological width

    immediate post operative, 3 month, 6 month and 1 year

Other Outcomes (1)

  • marginal integrity

    immediate post operative, 3 month, 6 month and 1 year

Study Arms (2)

intervention

EXPERIMENTAL

deep marginal acquisition using thermacut bur from dentsply

Procedure: deep marginal acquisition using thermacut bur

control

ACTIVE COMPARATOR

functional crown lengthening

Procedure: deep marginal acquisition using thermacut bur

Interventions

thermacut bur is a tool which doesn't contain any abrasives so it is much safer on the root surface of both prepared and adjacent teeth, and yields better treatment outcome in cases when exposing deep margins is needed.

Also known as: thermacut bur from dentsply
controlintervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Subject not less than 18 years of age
  • Males or females
  • Community-dwelling
  • Have at least one deep subgingival interproximal carious lesion.
  • Can comply to oral hygiene measures or with good oral hygiene
  • Have sufficient cognitive ability to
  • Understand consent procedures.

You may not qualify if:

  • Patients less than 18 years old.
  • Disabilities:
  • Systemic diseases or severe medically compromised. (Cardiovascular disorder, diabetes, hypertensive, epileptic).
  • Lack of compliance.
  • Gingival hyperplasia, blood disorder.
  • Cognitive impairment.
  • Attachment loss signs of periodontal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry Cairo university

Cairo, 11562, Egypt

RECRUITING

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
Master degree candidate, Conservative dentistry department, faculty of dentistry

Study Record Dates

First Submitted

April 26, 2020

First Posted

January 16, 2024

Study Start

February 2, 2024

Primary Completion

February 1, 2025

Study Completion

April 1, 2025

Last Updated

January 16, 2024

Record last verified: 2024-01

Locations