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

Study Overview
=================
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.

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

Conditions
-----------------
Gingival Retraction

Intervention / Treatment
-----------------
* Device: retraction cord
* Device: subgingival clamp


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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 |