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

Not Applicable

• Conditions: Gingival Retraction
• Interventions: Device: retraction cord; Device: subgingival clamp

• Registration Number: NCT03917108
• Lead Sponsor: Cairo University

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.

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 Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-15
• Last Update Submitted: 2019-04-15
• Study First Posted: 2019-04-16
• Last Update Posted: 2019-04-16
• Study Start: 2019-05
• Primary Completion: 2019-09
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
retraction cord	retraction cord	-
subgingival clamp	subgingival clamp	-

Primary Outcome Measures

Name	Time	Method
Degree of patient satisfaction	Immediately after application	Using visual analogue scale (units on scale from 0-10)
Time of application	Immediately after application	Assessed using timer and the measuring unite is seconds
Number of patients need local anesthesia	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	Immediately after application	Presence of cervical fluids will be assessed visually using magnifying loup with a Yes/No result

Secondary Outcome Measures

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