Effect of Retentive Rubber-Dam Clamps

The Effect of Retentive Rubber-Dam Clamps on Gingival Tissues During Restorative Treatment

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.

Study Overview

• Status: Completed
• Conditions: Gingival Health

Detailed Description

In the present study, it is aimed 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. The application time of the retention clamps were limited as maximum 2 hours. Before starting the treatment, patients signed information and consent forms. In the present study, direct composite restorations were planned under local anesthesia, and it was planned to evaluate the effects of retention clamps on periodontal tissues and patient comfort. After the isolation, direct composite restorations were performed.

- Data collection method Changes in periodontal tissues were evaluated; using plaque index, bleeding on probing, probing depth, keratinized gingiva, attached gingiva, relative gingival margin level, relative attachment level after the procedure at different times (pre-restoration, after restoration). It was evaluated immediately after, 1 week later, 1 month later, 3 months later. The evaluation time was planned not to exceed 10 minutes, restorations are done by a single specialist in Marmara University Restorative Dentistry Department.

Restorative materials used in the study; Nic Tone Thick (Dental Dam, Nic Tone, Romania) was used as a rubber-dam rubber cover for patients. In addition, sterile frames (Hu-Friedy Group, USA), forceps (Hu-Friedy Group, USA) and puncher (Hu-Friedy Group, USA) were used as rubber-dam instruments on patients. For gingival retention, Hu-Friedy Black Line 2X clamps (Hu-Friedy Group, USA) were used.

Clinical Index and Measurements Determination of Gingival Phenotype Evaluating the visibility of the silhouette of the periodontal probe inserted into the sulcus is a technique used to determine the phenotype. If the silhouette of the probe placed in the sulcus is visible, the gingiva is considered thin, and if it is not, the gingiva is considered thick.

Keratinized Gums The distance between the mucogingival junction and the gingival margin were 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.

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

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

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

Probing Depth 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.

Relative Attachment Level 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 was made in 6 regions, mesiobuccal, midbuccal, distobuccal, mesiopalatinal, midpalatinal, and distopalatinal surfaces of each tooth.

Relative Gingival Margin Level 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 6 regions of each tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual/palatinal, mesiopalatinal, midpalatinal, and distopalatinal surfaces.

Evaluation of Restorations Restorations were evaluated according to FDI (Fédération Dentaire Internationale) criteria.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34854
    • Marmara University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Retention clamp; Retention clamps applied to maxillary premolars during routine rubber dam isolation for performing anterior restorations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of probing depth immediately after 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.	Immediately after the treatment
Measurement of bleeding on probing immediately after 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.	Immediately after the treatment
Measurement of keratinized gingiva immediately after 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.	Immediately after the treatment
Measurement of attached gingiva immediately after the treatment	The distance between the mucogingival junction and the floor of gingival sulcus was measured as the width of the attached gingiva.	Immediately after the treatment
Measurement of relative gingival attachment level immediately after 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.	Immediately after the treatment
Measurement of relative gingival margin level immediately after 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.	Immediately after the treatment
Measurement of plaque index of 1 week control session	For each tooth, plaque index measurements were made from 4 regions as mesiobuccal, midbuccal, distobuccal, midpalatinal.	1 week after the treatment
Measurement of probing depth of 1 week control session	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.	1 week after the treatment
Measurement of bleeding on probing of 1 week control session	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.	1 week after the treatment
Measurement of keratinized gingiva of 1 week control session	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.	1 week after the treatment
Measurement of attached gingiva of 1 week control session	The distance between the mucogingival junction and the floor of gingival sulcus was measured as the width of the attached gingiva.	1 week after the treatment
Measurement of relative gingival margin level of 1 week control session	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.	1 week after the treatment
Measurement of relative attachment level of 1 week control session	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.	1 week after the treatment
Measurement of plaque index of 1 month control session	For each tooth, plaque index measurements were made from 4 regions as mesiobuccal, midbuccal, distobuccal, midpalatinal.	1 month after the treatment
Measurement of probing depth of 1 month control session	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.	1 month after the treatment
Measurement of bleeding on probing of 1 month control session	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.	1 month after the treatment
Measurement of keratinized gingiva of 1 month control session	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.	1 month after the treatment
Measurement of attached gingiva of 1 month control session	The distance between the mucogingival junction and the floor of gingival sulcus was measured as the width of the attached gingiva.	1 month after the treatment
Measurement of relative gingival margin level of 1 month control session	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.	1 month after the treatment
Measurement of relative attachment level of 1 month control session	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.	1 month after the treatment
Measurement of plaque index of 3 months control session	For each tooth, plaque index measurements were made from 4 regions as mesiobuccal, midbuccal, distobuccal, midpalatinal.	3 months after the treatment
Measurement of probing depth of 3 months control session	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.	3 months after the treatment
Measurement of bleeding on probing of 3 months control session	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.	3 months after the treatment
Measurement of keratinized gingiva of 3 months control session	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.	3 months after the treatment
Measurement of attached gingiva of 3 months control session	The distance between the mucogingival junction and the floor of gingival sulcus was measured as the width of the attached gingiva.	3 months after the treatment
Measurement of relative gingival margin level of 3 months control session	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.	3 months after the treatment
Measurement of relative attachment level of 3 months control session	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.	3 months after the treatment

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: EZGİ Tüter Bayraktar, Assistant Professor, Marmara University Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Actual): April 2, 2024
• Study Completion (Actual): September 16, 2024

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: gingival health; isolation; Direct restoration; retention clamp; rubber-dam application
• Other Study ID Numbers: 09.2023.1296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the publication of the article, data will be shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No