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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03917108
Enrollment
22
Registered
2019-04-16
Start date
2019-05-31
Completion date
2019-10-31
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Retraction

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.

Interventions

retraction cord ( Ultra dent sizes #0, #00, #000 ) is placed in the gingival sulcus using blunt instrument and using cotton roll isolation.

DEVICEsubgingival clamp

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

*

Design outcomes

Primary

MeasureTime frameDescription
Degree of patient satisfactionImmediately after applicationUsing visual analogue scale (units on scale from 0-10)
Time of applicationImmediately after applicationAssessed using timer and the measuring unite is seconds
Number of patients need local anesthesiaImmediately after applicationIt will be measured by patient self assessment for the need of local anesthesia through a Yes/No question
Degree of isolation from cervical fluidsImmediately after applicationPresence of cervical fluids will be assessed visually using magnifying loup with a Yes/No result

Secondary

MeasureTime frameDescription
Pink esthetics evaluation4 monthUsing a pink esthetic score with a grades from 0-2
Amount of gingival bleeding4 monthAssessed using a score for gingival hemorrhage from 0 -2
Presence of gingival laceration4 monthOccurence of gingival laceration assessed visually using magnifying loup with a Yes/No result
Degree of gingival sensitivity4 monthAssessed using visual analogue scale (units on scale from 0-10)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026