Subgingival Clamp Versus Retraction Cord in Cervical Lesions in Term of Technique Sensitivity and Gingival Health

• ClinicalTrials.gov Identifier: NCT03917108
• Recruitment Status: Unknown
• First Posted: April 16, 2019
• Last Update Posted: April 16, 2019
• Sponsor: Cairo University
• Information provided by (Responsible Party): Nada Hamada Ahmed Shehab Eldin, Cairo University

Study Description

Brief 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 satisfaction with the result.

Condition or disease	Intervention/treatment	Phase
Gingival Retraction	Device: retraction cord; Device: subgingival clamp	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• 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
• Estimated Study Start Date: May 2019
• Estimated Primary Completion Date: September 2019
• Estimated Study Completion Date: October 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: retraction cord	Device: retraction cord; retraction cord ( Ultra dent sizes #0, #00, #000 ) is placed in the gingival sulcus using blunt instrument and using cotton roll isolation.
subgingival clamp	Device: subgingival clamp; subgingival clamp (KSK clamps W8A, #44, #42, #43) or (Brinker clamps B5, B6) is placed to retract the gingiva with rubber dam isolation

Outcome Measures

Primary Outcome Measures :

1. Time of application [ Time Frame: Immediately after application ]
   Assessed using timer and the measuring unite is seconds
2. 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
3. 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
4. Degree of patient satisfaction [ Time Frame: Immediately after application ]
   Using visual analogue scale (units on scale from 0-10)

Secondary Outcome Measures :

1. Pink esthetics evaluation [ Time Frame: 4 month ]
   Using a pink esthetic score with a grades from 0-2
2. Amount of gingival bleeding [ Time Frame: 4 month ]
   Assessed using a score for gingival hemorrhage from 0 -2
3. Presence of gingival laceration [ Time Frame: 4 month ]
   Occurence of gingival laceration assessed visually using magnifying loup with a Yes/No result
4. Degree of gingival sensitivity [ Time Frame: 4 month ]
   Assessed using visual analogue scale (units on scale from 0-10)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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.
• 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.

Exclusion criteria:

• Exclusion Criteria:
• 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.
• 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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Nada Hamada Ahmed Shehab Eldin, principal investigator in Cairo university, Cairo University
• ClinicalTrials.gov Identifier: NCT03917108
• Other Study ID Numbers: 603
• First Posted: April 16, 2019
• Last Update Posted: April 16, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypersensitivity; Immune System Diseases