Comparison of Effectiveness of Gingival Displacement Using Retraction Cord and Aluminum Chloride Gel

NCT ID: NCT07255976

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-11
• Study Completion Date: 2025-12-30

Brief Summary

This study aims to compare the horizontal gingival displacement by using a retraction cord and aluminum chloride gel, and also to determine the time taken for placement and hemorrhage after the procedure by using a retraction cord and aluminum chloride gel. Patients of both genders, age ranges from 18 to 50 years, will be selecting requiring fixed prosthesis with of minimum two abutments. This study divided in two parallel groups of 33 patients in each group.

Detailed Description

To compare the effectiveness of a knitted retraction cord and 25% aluminum chloride-containing gel for horizontal gingival displacement, time taken for placement, patient discomfort and bleeding control after retraction cord removal and gel application with improved quality and better marginal fit of fixed prosthesis. This study include patients from range 18 to 50 years, Finishing line margins will be equigingival,Clinically and by radiographic analysis, healthy gingiva and periodontium around the abutments. Bleeding on probing index score-0 included,plaque index score(1-3) not included.

exclusion criteria is Sub-gingival or supra-gingival margins Patient having inappropriate root canal treated tooth. i.e Periapical pathosis over obturation, short root canal,Patient with probing depth 3mmm and above with uncontrolled bleeding. Patient with uncontrolled diabetes, hypertension or neurological disease.

SAMPLE TECHNIQUE: Non- probability consecutive sampling technique. Two groups will be formed among 66 patients with control group is retraction cord group and make two impressions after crown preparation with a finishing line Equiogingival margins will form than in group A in this study apply knitted retraction cord ultra Pak in thickness of .oo mm through retraction cord instrument by cord pecker retraction gel by company provided disposable tips with syringe into the circumferential area of sulcular preparation for 2 minutes and group B using gingival retraction gel containing 25% aluminum chloride viscous tat by ultra-dent after application of gingival retraction gel into sulcular area for 1-3minutes and wash with firm air water spray and will make impressions by one-step technique putty with the light body in metal stock trays then remove and check the impression for any inaccuracy then disinfect the impressions and pores with type 2 hard plaster and mention the code over cast that will not mix. The time required for placement of both gingival retraction systems will be recorded by using stopwatch in seconds and haemorrhage control will be checked by clinically observed with the naked eyes after air water spray up to 3 -5 seconds comparison of horizontal displacement on cast will be analyzed by stereomicroscope images using image analysis software at Dow dental lab.

Conditions

Gingival Bleeding; Prosthesis Failure, Dental; Tissue Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Retraction cord

Conventionally used knitted cotton retraction cord

Group Type: ACTIVE_COMPARATOR

knitted cotton retraction cord

Intervention Type: DEVICE

00 size knitted cotton gingival displacement cord used as a control

Aluminum chloride gel

experimental 25% aluminum chloride gel retraction

Group Type: EXPERIMENTAL

aluminum chloride gel

Intervention Type: DEVICE

25% Aluminum chloride gel used as an experimental intervention

Interventions

knitted cotton retraction cord

00 size knitted cotton gingival displacement cord used as a control

Intervention Type: DEVICE

aluminum chloride gel

25% Aluminum chloride gel used as an experimental intervention

Intervention Type: DEVICE

Other Intervention Names

conventional displacement cord

Eligibility Criteria

Inclusion Criteria

1. age ranges from 18 to 50 years a fixed prosthesis with minimum of two abutments.

2. minimum of two abutments

3. Finishing line margins will be Equiogingival

4. Clinically healthy gingiva and periodontium.

Exclusion Criteria

• 1. Sub-gingival or supra-gingival margins 2 Periapical pathosis 3. inadequate obturated root canals 4. bleeidng disorder 5.uncontrolled diabetes, 6.hypertension 7.neurological disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr Armeen Fakhur

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Armeen Fakhur, bds

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Locations

Armeen Fakhur

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Armeen Fakhur, bds

Role: CONTACT

armeenfakhur.401050@duhs.edu.pk

03439269593

Facility Contacts

Armeen Fakhur, bds

Role: primary

armeenfakhur.401050@duhs.edu.pk

03439269593

Other Identifiers

Dr Armeen Fakhur

Identifier Type: -

Identifier Source: org_study_id