Gingival HealthNCT06611735
Effect of Retentive Rubber-Dam Clamps
An observational study of Gingival Health, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Health
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 16 Sep 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who attended Marmara University Faculty of Dentistry Restorative Department, for the anterior restorations.
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- Signs of periapical pathology or pulpal posterior or anterior pathology
- Teeth which have mobility
- Teeth with extraction indication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Dentistry
Istanbul, 34854
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingival Health
- Keywords
- Direct restoration, gingival health, isolation, retention clamp, rubber-dam application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retention clamp | Retention clamps applied to maxillary premolars during routine rubber dam isolation for performing anterior restorations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of plaque index before the treatment
For each tooth, plaque index measurements were made from 4 regions as mesiobuccal, midbuccal, distobuccal, midpalatinal.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before the treatment
Secondary outcomes (27)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start2 Jan 2024
- Primary completion2 Apr 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival HealthStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EZGİ Tüter Bayraktar, Assistant Professor, Principal investigator, Marmara University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611735
- Sponsor's protocol ID
- 09.2023.1296
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication of the article, data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Retentive Rubber-Dam Clamps on Gingival Tissues During Restorative Treatment
- ClinicalTrials.gov ID
- NCT06611735
- Acronym / sponsor ID
- 09.2023.1296
- Conditions
- Gingival Health
- Keywords
- Direct restoration, gingival health, isolation, retention clamp, rubber-dam application
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retention clamp | – | –Retention clamps applied to maxillary premolars during routine rubber dam isolation for performing anterior restorations. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who attended Marmara University Faculty of Dentistry Restorative Department, for the anterior restorations.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of plaque index before the treatment
Time frame: Before the treatment
For each tooth, plaque index measurements were made from 4 regions as mesiobuccal, midbuccal, distobuccal, midpalatinal.
Measurement of probing depth before the treatment
Time frame: 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.
Measurement of bleeding on probing before the treatment
Time frame: 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.
Measurement of keratinized gingiva before the treatment
Time frame: 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.
Measurement of attached gingiva before the treatment
Time frame: Before the treatment
The distance between the mucogingival junction and the floor of gingival sulcus was measured as the width of the attached gingiva.
Measurement of relative gingival margin level before the treatment
Time frame: 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.
Measurement of relative attachment level before the treatment
Time frame: 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.
27 secondary outcomes
Measurement of probing depth immediately after the treatment
Time frame: Immediately after the treatment
Measurement of bleeding on probing immediately after the treatment
Time frame: Immediately after the treatment
Measurement of keratinized gingiva immediately after the treatment
Time frame: Immediately after the treatment
Measurement of attached gingiva immediately after the treatment
Time frame: Immediately after the treatment
Measurement of relative gingival attachment level immediately after the treatment
Time frame: Immediately after the treatment
Measurement of relative gingival margin level immediately after the treatment
Time frame: Immediately after the treatment
Measurement of plaque index of 1 week control session
Time frame: 1 week after the treatment
Measurement of probing depth of 1 week control session
Time frame: 1 week after the treatment
Measurement of bleeding on probing of 1 week control session
Time frame: 1 week after the treatment
Measurement of keratinized gingiva of 1 week control session
Time frame: 1 week after the treatment
Measurement of attached gingiva of 1 week control session
Time frame: 1 week after the treatment
Measurement of relative gingival margin level of 1 week control session
Time frame: 1 week after the treatment
Measurement of relative attachment level of 1 week control session
Time frame: 1 week after the treatment
Measurement of plaque index of 1 month control session
Time frame: 1 month after the treatment
Measurement of probing depth of 1 month control session
Time frame: 1 month after the treatment
Measurement of bleeding on probing of 1 month control session
Time frame: 1 month after the treatment
Measurement of keratinized gingiva of 1 month control session
Time frame: 1 month after the treatment
Measurement of attached gingiva of 1 month control session
Time frame: 1 month after the treatment
Measurement of relative gingival margin level of 1 month control session
Time frame: 1 month after the treatment
Measurement of relative attachment level of 1 month control session
Time frame: 1 month after the treatment
Measurement of plaque index of 3 months control session
Time frame: 3 months after the treatment
Measurement of probing depth of 3 months control session
Time frame: 3 months after the treatment
Measurement of bleeding on probing of 3 months control session
Time frame: 3 months after the treatment
Measurement of keratinized gingiva of 3 months control session
Time frame: 3 months after the treatment
Measurement of attached gingiva of 3 months control session
Time frame: 3 months after the treatment
Measurement of relative gingival margin level of 3 months control session
Time frame: 3 months after the treatment
Measurement of relative attachment level of 3 months control session
Time frame: 3 months after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: Yes. After the publication of the article, data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EZGİ Tüter Bayraktar, Assistant Professor principal investigator
Marmara University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Health, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of plaque index before the treatment (time frame: Before the treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.