An observational study in Gingival Health, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Marmara University · Observational
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.
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.
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.
Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who attended Marmara University Faculty of Dentistry Restorative Department, for the anterior restorations.
Exclusion Criteria:
Retention clamps applied to maxillary premolars during routine rubber dam isolation for performing anterior restorations.
Measurement of plaque index before the treatment
For each tooth, plaque index measurements were made from 4 regions as mesiobuccal, midbuccal, distobuccal, midpalatinal.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before the treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months after the treatment
Plan to share: Yes — After the publication of the article, data will be shared.
Supporting information: Study protocol, Sap
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