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

NCT03917108 | Unknown

• 1 other identifier: 603
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingival Retraction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Pink esthetics evaluation

  4 month

• Amount of gingival bleeding

  4 month

• Presence of gingival laceration

  4 month

• Degree of gingival sensitivity

  4 month

Study Arms (2)

retraction cord

ACTIVE COMPARATOR

Device: retraction cord

subgingival clamp

OTHER

Device: subgingival clamp

Interventions

retraction cord DEVICE

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

retraction cord

subgingival clamp DEVICE

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

subgingival clamp

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator in Cairo university

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: May 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04