Effect of Retentive Rubber-Dam Clamps

NCT06611735 | Completed

• 1 other identifier: 09.2023.1296
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of retention rubber dam clamps used on premolar teeth during rubber dam isolation on gingival health. The teeth to which retention clamps are applied were not undergo any restorative procedures. Retention clamps applied to maxillary premolars during routine rubber dam isolation for performing anterior restorations. Changes in periodontal tissues were evaluated; using plaque index, bleeding on probing, probing depth, keratinized gingiva, attached gingiva, relative gingival margin level and relative attachment levels after the procedure at different times (pre-restoration, after restoration, 1 week, 1 month, 3 month). The evaluation time was planned not to exceed 10 minutes, restorations are done by a single specialist in Marmara University Restorative Dentistry Department.

Conditions

Gingival Health

Keywords

Direct restoration; gingival health; isolation; retention clamp; rubber-dam application

Outcome Measures

Primary Outcomes (7)

• Measurement of plaque index before the treatment

  For each tooth, plaque index measurements were made from 4 regions as mesiobuccal, midbuccal, distobuccal, midpalatinal.

  Before the treatment

• Measurement of probing depth before the treatment

  For each of the initially selected teeth, probing depth measurements were made in a total of 6 regions: mesiobuccal, midbuccal, distobuccal, mesiopalatinal, midpalatinal, and distopalatinal surfaces.

  Before the treatment

• Measurement of bleeding on probing before the treatment

  Bleeding on probing was examined in 6 regions of each tooth: mesiobuccal, midbuccal, distobuccal, mesiopalatinal, midpalatinal, and distopalatinal. (+) or (-) values will be given according to the presence or absence of bleeding that occurs after the Unc (University of North Carolina) probe examination.

  Before the treatment

• Measurement of keratinized gingiva before the treatment

  The distance between the mucogingival junction and the gingival margin was measured as the width of the keratinized gingiva after the alveolar mucosa was pushed and curved coronally and with periodontal probe and the mucogingival junction was determined.

  Before the treatment

• Measurement of attached gingiva before the treatment

  The distance between the mucogingival junction and the floor of gingival sulcus was measured as the width of the attached gingiva.

  Before the treatment

• Measurement of relative gingival margin level before the treatment

  Using the Chu\'s Gauge handpiece, it was placed on the incisal edge of the incisors, the incisal guide edge of the handpiece was taken as the fixed guide point, and the distance between the incisal guide and the gingival margin was measured and recorded. Relative gingival margin level measurement was made in a total of 3 regions of each tooth: mesiobuccal, midbuccal, and distobuccal surfaces.

  Before the treatment

• Measurement of relative attachment level before the treatment

  Using the Chu\'s Gauge handpiece, it was placed on the incisal edge of the incisors, the incisal guide edge of the handpiece was taken as the fixed guide point, and the distance between the floor of gingival sulcus and the incisal guide edge was measured and recorded with a periodontal probe. Relative attachment level measurement will be made in 3 regions, mesiobuccal, midbuccal, distobuccal surfaces of each tooth.

  Before the treatment

Secondary Outcomes (27)

• Measurement of probing depth immediately after the treatment

  Immediately after the treatment

• Measurement of bleeding on probing immediately after the treatment

  Immediately after the treatment

• Measurement of keratinized gingiva immediately after the treatment

  Immediately after the treatment

• Measurement of attached gingiva immediately after the treatment

  Immediately after the treatment

• Measurement of relative gingival attachment level immediately after the treatment

  Immediately after the treatment

Study Arms (1)

Retention clamp

Retention clamps applied to maxillary premolars during routine rubber dam isolation for performing anterior restorations.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients who attended Marmara University Faculty of Dentistry Restorative Department, for the anterior restorations.

You may qualify if:

• 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
• 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 anterior region.

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
• Teeth which have mobility
• Teeth with extraction indication

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

Study Officials

• EZGİ Tüter Bayraktar, Assistant Professor

  Marmara University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 25, 2024
• Study Start: January 2, 2024
• Primary Completion: April 2, 2024
• Study Completion: September 16, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)