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

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.

Study Overview

• Status: Recruiting
• Conditions: Tissue Injury; Gingival Bleeding; Prosthesis Failure, Dental
• Intervention / Treatment: Device: knitted cotton retraction cord; Device: aluminum chloride gel

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Armeen Fakhur, bds; Phone Number: 03439269593; Email: armeenfakhur.401050@duhs.edu.pk

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Recruiting
      • Armeen Fakhur
      • Contact: Armeen Fakhur, bds; Phone Number: 03439269593; Email: armeenfakhur.401050@duhs.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Retraction cord; Conventionally used knitted cotton retraction cord	Device: knitted cotton retraction cord; 00 size knitted cotton gingival displacement cord used as a control; Other Names: conventional displacement cord
Experimental: Aluminum chloride gel; experimental 25% aluminum chloride gel retraction	Device: aluminum chloride gel; 25% Aluminum chloride gel used as an experimental intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
horizontal gingival displacement	Horizontal displacement will be analyzed on casts using stereomicroscope imaging and image analysis software at Dow Dental Lab. and measurment in micron meter unit.	one time intervention , measure at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
placement time	time for placement will be recorded with a stopwatch.	one time intervention , measure at baseline
bleeding control	bleeding control will be visual assist by after applying air-water spray.	one time intervention , measure at baseline

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Principal Investigator: Armeen Fakhur, bds, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Estimated): December 15, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Hemorrhage; Gingival Diseases; Oral Hemorrhage; Pathological Conditions, Signs and Symptoms; Gingival Hemorrhage; Prosthesis Failure
• Other Study ID Numbers: Dr Armeen Fakhur

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No