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

Gingival Retraction Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03917108
• Other study ID #: 603
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2019
• Est. completion date: October 2019

Study information

• Verified date: April 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 satisfaction with the result.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: October 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Retraction

Intervention

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
subgingival clamp (KSK clamps W8A, #44, #42, #43) or (Brinker clamps B5, B6) is placed to retract the gingiva with rubber dam isolation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of application	Assessed using timer and the measuring unite is seconds	Immediately after application
Primary	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	Immediately after application
Primary	Degree of isolation from cervical fluids	Presence of cervical fluids will be assessed visually using magnifying loup with a Yes/No result	Immediately after application
Primary	Degree of patient satisfaction	Using visual analogue scale (units on scale from 0-10)	Immediately after application
Secondary	Pink esthetics evaluation	Using a pink esthetic score with a grades from 0-2	4 month
Secondary	Amount of gingival bleeding	Assessed using a score for gingival hemorrhage from 0 -2	4 month
Secondary	Presence of gingival laceration	Occurence of gingival laceration assessed visually using magnifying loup with a Yes/No result	4 month
Secondary	Degree of gingival sensitivity	Assessed using visual analogue scale (units on scale from 0-10)	4 month