Gingival RetractionNCT03917108
Subgingival Clamp Versus Retraction Cord in Cervical Lesions in Term of Technique Sensitivity and Gingival Health
A study testing retraction cord and subgingival clamp in people with Gingival Retraction, run by Cairo University.
Trial summary
assessing subgingival clamp in handling and retracting the gingival tissue at the cervical area to see its effect on the gingival health and its technique sensitivity compared to the most commonly used method (retraction cord), as gingival displacement for cervical restorations affects smile and therefore patient… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Retraction
- What is being tested?
- retraction cord and subgingival clamp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Oct 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject not less than 18 years of age.
- Males or females.
- Have at least one carious or non-carious cervical lesion.
- Cervical lesions should be equi-gingival or subgingival.
- Can comply to oral hygiene measures or with good oral hygiene.
- Have sufficient cognitive ability to understand consent procedures.
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- Vital upper or lower teeth with no signs or symptoms of irreversible pulpitis.
- Clinically healthy gingiva and periodontium.
- No evidence of attachment loss, bleeding on probing, or plaque accumulation.
Who cannot join
- Patients less than 18 years old.
- Disabilities (mental health conditions, intellectual disability and physical disabilities).
- Systemic diseases or severe medically compromised. (Cardiovascular disorder, diabetes, -hypertensive, epileptic.
- Lack of compliance.
- Gingival hyperplasia, blood disorder.
- Attachment loss signs of periodontal disease.
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- Patients contra-indicated for rubber dam placement (Asthmatic patient, mouth breather, -- partially erupted tooth, extremely malposed teeth and latex allergy).
- Periapical pathosis or signs of pulpal posterior or anterior pathology.
- Non-vital tooth.
- Endodontically treated tooth.
- Sever periodontal affection.
- Tooth indicated for extraction.
About this study
Official title: Assessment of Technique Sensitivity and Gingival Health in Management of Cervical Lesions Performed Using Subgingival Clamp Versus Retraction Cord: A Randomized Controlled Clinical Trial
assessing subgingival clamp in handling and retracting the gingival tissue at the cervical area to see its effect on the gingival health and its technique sensitivity compared to the most commonly used method (retraction cord), as gingival displacement for cervical restorations affects smile and therefore patient satisfaction with the result.
Read the detailed description
Gingival displacement for restoring cervical lesions using retraction cord or subgingival clamp with their technique sensitivity affects the smile as they may cause gingival bleeding, laceration or recession and therefore affects patient satisfaction. There are several methods to achieve retraction; retraction cord is the most commonly used method. It controls the soft tissue displacement, gingival bleeding and expose the margins which provide good visualization and access.
They are effective and safe if the gingiva is healthy, also inexpensive retraction method. However, the use of retraction cord has some disadvantages like: it is time consuming, may cause gingival recession after healing and bleeding after removal, its application needs practice and skill as improper handling of the cord can cause traumatic injuries, gingival recession and marginal exposure of the restoration, it may cause postoperative discomfort and pain for the patient and finally leaving the retraction cord for long time or forgetting to remove it from the sulcus can cause permanent damage to the gingival tissue.
Using gingival retracting clamps with rubber dam isolation prevent the gap caused around the teeth due to vertical and horizontal tissue displacement occurred beneath the area of dento-gingival attachment upon the application of the retraction cord. Also, after clamp stabilization in position, it prevents accidental slippage and trauma to surrounding soft tissue during the restorative procedure. They also provide maximum tissue retraction without laceration of gingival tissues. Also, their availability in different sizes and shapes provide a good adaptation to any tooth configuration and any inaccessible area.
- Conditions
- Gingival Retraction
- Being tested
- retraction cord, subgingival clamp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retraction cordDevice
retraction cord ( Ultra dent sizes #0, #00, #000 ) is placed in the gingival sulcus using blunt instrument and using cotton roll isolation.
subgingival clampDevice
subgingival clamp (KSK clamps W8A, #44, #42, #43) or (Brinker clamps B5, B6) is placed to retract the gingiva with rubber dam isolation
| Study group | Role | What they receive |
|---|---|---|
| retraction cord | Active comparator | Not described Receives: Device: retraction cord |
| subgingival clamp | Other | Not described Receives: Device: subgingival clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of application
Assessed using timer and the measuring unite is seconds
Measured: Immediately after application
Number of patients need local anesthesia
It will be measured by patient self assessment for the need of local anesthesia through a Yes/No question
Measured: Immediately after application
Degree of isolation from cervical fluids
Presence of cervical fluids will be assessed visually using magnifying loup with a Yes/No result
Measured: Immediately after application
Degree of patient satisfaction
Using visual analogue scale (units on scale from 0-10)
Measured: Immediately after application
Secondary outcomes (4)
Pink esthetics evaluation
Using a pink esthetic score with a grades from 0-2
Measured: 4 month
Amount of gingival bleeding
Assessed using a score for gingival hemorrhage from 0 -2
Measured: 4 month
Presence of gingival laceration
Occurence of gingival laceration assessed visually using magnifying loup with a Yes/No result
Measured: 4 month
Degree of gingival sensitivity
Assessed using visual analogue scale (units on scale from 0-10)
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study startMay 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RetractionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Hamada Ahmed Shehab Eldin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917108
- Sponsor's protocol ID
- 603
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Technique Sensitivity and Gingival Health in Management of Cervical Lesions Performed Using Subgingival Clamp Versus Retraction Cord: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03917108
- Acronym / sponsor ID
- 603
- Conditions
- Gingival Retraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 16 Apr 2019 (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.
assessing subgingival clamp in handling and retracting the gingival tissue at the cervical area to see its effect on the gingival health and its technique sensitivity compared to the most commonly used method (retraction cord), as gingival displacement for cervical restorations affects smile and therefore patient satisfaction with the result.
Detailed description
Gingival displacement for restoring cervical lesions using retraction cord or subgingival clamp with their technique sensitivity affects the smile as they may cause gingival bleeding, laceration or recession and therefore affects patient satisfaction. There are several methods to achieve retraction; retraction cord is the most commonly used method. It controls the soft tissue displacement, gingival bleeding and expose the margins which provide good visualization and access.
They are effective and safe if the gingiva is healthy, also inexpensive retraction method. However, the use of retraction cord has some disadvantages like: it is time consuming, may cause gingival recession after healing and bleeding after removal, its application needs practice and skill as improper handling of the cord can cause traumatic injuries, gingival recession and marginal exposure of the restoration, it may cause postoperative discomfort and pain for the patient and finally leaving the retraction cord for long time or forgetting to remove it from the sulcus can cause permanent damage to the gingival tissue.
Using gingival retracting clamps with rubber dam isolation prevent the gap caused around the teeth due to vertical and horizontal tissue displacement occurred beneath the area of dento-gingival attachment upon the application of the retraction cord. Also, after clamp stabilization in position, it prevents accidental slippage and trauma to surrounding soft tissue during the restorative procedure. They also provide maximum tissue retraction without laceration of gingival tissues. Also, their availability in different sizes and shapes provide a good adaptation to any tooth configuration and any inaccessible area.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retraction cord | Active comparator | Device: retraction cord |
| subgingival clamp | Other | Device: subgingival clamp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject not less than 18 years of age.
- Males or females.
- Have at least one carious or non-carious cervical lesion.
- Cervical lesions should be equi-gingival or subgingival.
- Can comply to oral hygiene measures or with good oral hygiene.
Key exclusion criteria (12 listed)
- Patients less than 18 years old.
- Disabilities (mental health conditions, intellectual disability and physical disabilities).
- Systemic diseases or severe medically compromised. (Cardiovascular disorder, diabetes, -hypertensive, epileptic.
- Lack of compliance.
- Gingival hyperplasia, blood disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retraction cordretraction cord ( Ultra dent sizes #0, #00, #000 ) is placed in the gingival sulcus using blunt instrument and using cotton roll isolation. | Device | retraction cord |
| subgingival clampsubgingival clamp (KSK clamps W8A, #44, #42, #43) or (Brinker clamps B5, B6) is placed to retract the gingiva with rubber dam isolation | Device | subgingival clamp |
Primary outcome
Time of application
Time frame: Immediately after application
Assessed using timer and the measuring unite is seconds
Number of patients need local anesthesia
Time frame: Immediately after application
It will be measured by patient self assessment for the need of local anesthesia through a Yes/No question
Degree of isolation from cervical fluids
Time frame: Immediately after application
Presence of cervical fluids will be assessed visually using magnifying loup with a Yes/No result
Degree of patient satisfaction
Time frame: Immediately after application
Using visual analogue scale (units on scale from 0-10)
4 secondary outcomes
Pink esthetics evaluation
Time frame: 4 month
Amount of gingival bleeding
Time frame: 4 month
Presence of gingival laceration
Time frame: 4 month
Degree of gingival sensitivity
Time frame: 4 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing retraction cord and subgingival clamp in people with Gingival Retraction, run by Cairo University.
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 12 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Time of application (time frame: Immediately after application). The study lists 4 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 16 Apr 2019.