NCT05850065

Brief Summary

The aim of this study is to evaluate the effect of retraction techniques on gingival health. Four different method (212 clamp (Hu-Friedy, USA); Brinker B4 clamp (Coltene Hygenic, USA); dental floss using the simple knot tie method; and using the simple knot tie and 212 clamp together) will evaluated. After rubber dam isolation restorations will be performed, each restoration will take maximum 30 minutes. Changes in periodontal tissues will be evaluate; using plaque index, bleeding on probing, probing depth, keratinized gingiva, attached gingiva, relative gingival margin level, relative attachment level and VAS (visual analogue scale) scoring and patient comfort levels after the procedure at different times (pre-restoration, after restoration, 1 week, 1 month, 3 month). The evaluation time is planned not to exceed 10 minutes, restorations are done by a single specialist in Marmara University Restorative Dentistry Department.

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 Mar 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 12, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

April 5, 2023

Last Update Submit

May 11, 2023

Conditions

Gingival Recession, Localized

Keywords

RetractionRubber-dam isolationClampGingival health

Outcome Measures

Primary Outcomes (8)

  • Relative Attachment Level

    Relative Attachment Level will measure for the evaluate to effect of different retraction methods on gingival tissue

    Immediately after the restorations

  • Relative Attachment Level

    Relative Attachment Level will measure for the evaluate to effect of different retraction methods on gingival tissue

    1 week later

  • Relative Attachment Level

    Relative Attachment Level will measure for the evaluate to effect of different retraction methods on gingival tissue

    1 month later

  • Relative Attachment Level

    Relative Attachment Level will measure for the evaluate to effect of different retraction methods on gingival tissue

    3 months later

  • Relative Gingival Margin Level

    Relative Gingival Margin Level will measure for the evaluate to effect of different retraction methods on gingival tissue

    Immediately after the restorations

  • Relative Gingival Margin Level

    Relative Gingival Margin Level will measure for the evaluate to effect of different retraction methods on gingival tissue

    1 week later

  • Relative Gingival Margin Level

    Relative Gingival Margin Level will measure for the evaluate to effect of different retraction methods on gingival tissue

    1 month later

  • Relative Gingival Margin Level

    Relative Gingival Margin Level will measure for the evaluate to effect of different retraction methods on gingival tissue

    3 months later

Study Arms (4)

Hu-Friedy 212 clamp

OTHER

Hu-Friedy 212 clamp will used for the retraction.

Other: Hu-Friedy 212 clamp

dental floss using the simple knot tie method

OTHER

Dental floss using the simple knot tie method will used for the retraction.

Other: dental floss using the simple knot tie method

Using Hu-Friedy 212 clamp and dental floss using the simple knot tie method together

OTHER

Using Hu-Friedy 212 clamp and dental floss using the simple knot tie method together will used for the retraction.

Other: Hu-Friedy 212 clampOther: dental floss using the simple knot tie method

Coltene B4 clamp

OTHER

Coltene B4 clamp will used for the retraction.

Other: Coltene B4 clamp

Interventions

Hu-Friedy 212 clampOTHER

Hu-Friedy 212 clamp is normally used for the retraction with rubber-dam

Hu-Friedy 212 clampUsing Hu-Friedy 212 clamp and dental floss using the simple knot tie method together
dental floss using the simple knot tie methodOTHER

Dental floss using the simple knot tie method is normally used for the retraction with rubber-dam

Using Hu-Friedy 212 clamp and dental floss using the simple knot tie method togetherdental floss using the simple knot tie method
Coltene B4 clampOTHER

Coltene B4 clamp is normally used for the retraction with rubber-dam

Coltene B4 clamp

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-35
  • Have sufficient cognitive ability to understand the consent procedure
  • Clinically healthy gingiva and periodontium
  • Daily cigarette consumption of 10 or less
  • No attachment loss, bleeding on probing, or plaque buildup
  • Vital upper teeth (12-22) without signs of irreversible pulpitis
  • Patients with cervical lesions, abrasion lesions and/or indications for diastema closure requiring restoration
  • Patients with cervical lesions at or below the gingival level
  • Patients with direct composite restoration indications concerning the cervical region in their upper anterior 4 incisors.

You may not qualify if:

  • Any disability (mental health conditions, mentally handicapped and physically handicapped)
  • Systemic diseases or serious medical risks (Cardiovascular disorder, diabetes, hypertensive, epileptic)
  • Compliance problem, inability to provide post-treatment hygiene
  • Gingival hyperplasia or bleeding disorder
  • Signs of attachment loss of periodontal disease
  • Patients for whom rubber dam placement is contraindicated (patient with asthma diagnosis, mouth breathing, partially erupted tooth, overly malpositioned teeth and latex allergy).
  • Signs of periapical pathology or pulpal posterior or anterior pathology
  • Non-vital, endodontically treated teeth
  • Teeth which have mobility
  • Teeth with extraction indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Ezgi Tüter Bayraktar, Asst. Prof

    Marmara University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ezgi Tüter Bayraktar

CONTACT

5382336416ezgi.tuter@marmara.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2023

First Posted

May 9, 2023

Study Start

March 10, 2023

Primary Completion

December 10, 2023

Study Completion

September 1, 2024

Last Updated

May 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Data will be shared after the article of the study published in an international journal.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
2 years
Access Criteria
Data will be shared after the article of the study published in an international journal.

Locations

TU(1)