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Gingival Recession, LocalizedNCT05850065

Assessment of Gingival Health Following Rubber-Dam Isolation

A study testing Hu-Friedy 212 clamp, dental floss using the simple knot tie method and Coltene B4 clamp in people with Gingival Recession, Localized, run by Marmara University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession, Localized
What is being tested?
Hu-Friedy 212 clamp, dental floss using the simple knot tie method and Coltene B4 clamp
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Mar 2023to 1 Sep 2024
Phase
Interventional
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

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

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 10Show fewer
  • Signs of periapical pathology or pulpal posterior or anterior pathology
  • Non-vital, endodontically treated teeth
  • Teeth which have mobility
  • Teeth with extraction indication

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting
  • Marmara University Faculty of Dentistry

    Istanbul

    Ezgi Tüter Bayraktar, 5382336416 ext. +90, tuterezgi@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Assessment of Gingival Health Following Different Retraction Techniques in Restorative Rubber-Dam Isolation

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.

Read the detailed description

In the present study study, it is aimed to perform gingival retraction under rubber-dam isolation by using a 212 clamp (Hu-Friedy, USA), a Brinker B4 clamp (Coltene Hygenic, USA), dental floss using the simple knot tie method, and using the simple knot tie and 212 clamp together. The study was planned as a split mouth. All of these methods will be applied systematically on upper incisors of each patient (teeth numbered 11-12-21-22) by changing them in a clockwise direction. The application time of the retraction methods in each tooth will be limited to 30 minutes, the working time is planned as 2 hours for a total of 4 teeth.

Before starting the treatment, patients will have to sign information and consent forms. In the present study, direct composite restorations are planned under local anesthesia, and it is planned to evaluate the effects of different retraction methods on periodontal tissues and patient comfort. After the retraction technique to be used, direct composite restorations will be performed. Restorations involving the cervical region veneer restorations; It will include aesthetic restorations in the maxillary anterior region, including cervical area. The preparation will only be made when necessary and will protect the hard tissues of the teeth as much as possible in minimally invasive way.

All restorations to be made in our study are planned to be applied with the 'additive' finishing technique. In this technique, the resin material is placed on the tooth surface in small pieces during composite layering and no 'overcontouring' is made. In this way, it is not necessary to reduce the areas close to the gingiva with a drill during the finishing of the restorations, especially concerning the cervical region, and periodontal tissues can be protected. In our study, it is aimed to eliminate the use of burs in the cervical area, which is an important parameter of possible damage to periodontal tissues, and to observe the effects of retraction methods by using this technique.

  • Data collection method 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). It will be evaluated immediately after, 1 week later, 1 month later, 3 months later. The evaluation time is planned not to exceed 10 minutes, restorations are done by a single specialist in Marmara University Restorative Dentistry Department. Periodontal evaluations will be performed as a single blind, the observer will not know which retraction method is applied to which teeth during the evaluation. Intra-observer agreement will be evaluated, and work will continue in the presence of agreement above 80%.

Restorative materials to be used in the study; Estelite Asteria (Tokuyama, Japan) with nano-hybrid properties will be used as resin composite for the restorations. A 37.5% phosphoric acid (Gel Etchant, Kerr Dental, USA) and a universal agent Tokuyama Universal Bond II (Tokuyama) will be used. For polymerization, Valo Cordless (Ultradent Products, USA) will be used in standard mode (/1000 mw/cm2). In case of, preparation is required, the type of atraumatic burs to be used as much as possible, red or yellow banded diamond burs (Acurata, Japan) and multi-blade tungsten carbide burs (Acurata) will be preferred.

The patients will be isolated with a rubber-dam under local anesthesia and the clamps to be used will be systematically applied to the maxillary incisors.

Nic Tone Thick (Dental Dam, Nic Tone, Romania) will be 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) will be used as rubber-dam instruments on patients. For gingival retraction, Hu-Friedy #212 clamp (Hu-Friedy Group, USA), Coltene B4 Brinker clamp (Coltene/ Whaledent, Switzerland) and waxed dental floss (gum) will be 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 will be measured as the width of the keratinized gingiva after the alveolar mucosa is pushed and curved coronally and with periodontal probe and the mucogingival junction is determined.

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

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

Bleeding on Probing Bleeding on probing will be 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.

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

Visual Analogue Scale (VAS) On the 1st and 7th days after retraction using VAS, the patient will be asked to score the pain in the relevant regions between 1 and 10 according to its severity.

Relative Attachment Level Using the Chu's Gauge handpiece, it will be placed on the incisal edge of the incisors, the incisal guide edge of the handpiece will be taken as the fixed guide point, and the distance between the floor of gingival sulcus and the incisal guide edge will be measured and recorded with a periodontal probe. Relative attachment level measurement will be 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 will be placed on the incisal edge of the incisors, the incisal guide edge of the handpiece will be taken as the fixed guide point, and the distance between the incisal guide and the gingival margin will be measured and recorded. Relative gingival margin level measurement will be made in a total of 6 regions of each tooth: mesiobuccal, midbuccal, distobuccal, mesiolingual/palatinal, mesiopalatinal, midpalatinal, and distopalatinal surfaces.

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

Being tested
Hu-Friedy 212 clamp, dental floss using the simple knot tie method, Coltene B4 clamp
Keywords
Retraction, Rubber-dam isolation, Clamp, Gingival health
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hu-Friedy 212 clampOther

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

  • 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

  • Coltene B4 clampOther

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

Study groups in NCT05850065
Study groupRoleWhat they receive
Hu-Friedy 212 clampOtherHu-Friedy 212 clamp will used for the retraction.
Receives: Other: Hu-Friedy 212 clamp
dental floss using the simple knot tie methodOtherDental floss using the simple knot tie method will used for the retraction.
Receives: Other: dental floss using the simple knot tie method
Using Hu-Friedy 212 clamp and dental floss using the simple knot tie method togetherOtherUsing Hu-Friedy 212 clamp and dental floss using the simple knot tie method together will used for the retraction.
Receives: Other: Hu-Friedy 212 clamp; Other: dental floss using the simple knot tie method
Coltene B4 clampOtherColtene B4 clamp will used for the retraction.
Receives: Other: Coltene B4 clamp

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative Attachment Level

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

    Measured: Immediately after the restorations

  2. Relative Attachment Level

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

    Measured: 1 week later

  3. Relative Attachment Level

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

    Measured: 1 month later

  4. Relative Attachment Level

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

    Measured: 3 months later

  5. Relative Gingival Margin Level

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

    Measured: Immediately after the restorations

  6. Relative Gingival Margin Level

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

    Measured: 1 week later

  7. Relative Gingival Margin Level

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

    Measured: 1 month later

  8. Relative Gingival Margin Level

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

    Measured: 3 months later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2023
  2. Study start10 Mar 2023
  3. Primary completion10 Dec 2023 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05850065
Sponsor's protocol ID
09.2023.126
Status last verified
Apr 2023
First submitted
5 Apr 2023
Last updated
12 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared after the article of the study published in an international journal.

Questions about this trial

What is this clinical trial studying?

A study testing Hu-Friedy 212 clamp, dental floss using the simple knot tie method and Coltene B4 clamp in people with Gingival Recession, Localized, 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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 May 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ezgi Tüter Bayraktar (5382336416 ext. +90, ezgi.tuter@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative Attachment Level (time frame: Immediately after the restorations). The study lists 8 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 12 May 2023.

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