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

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.

Study Overview

• Status: Unknown
• Conditions: Gingival Retraction
• Intervention / Treatment: Device: retraction cord; Device: subgingival clamp

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 Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of application	Assessed using timer and the measuring unite is seconds	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	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	Immediately after application
Degree of patient satisfaction	Using visual analogue scale (units on scale from 0-10)	Immediately after application

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 603

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No