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

NCT07255976 | Recruiting Phase 4 DMC

• 1 other identifier: Dr Armeen Fakhur
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Bleeding; Prosthesis Failure, Dental; Tissue Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• placement time

  one time intervention , measure at baseline

• bleeding control

  one time intervention , measure at baseline

Study Arms (2)

Retraction cord

ACTIVE COMPARATOR

Conventionally used knitted cotton retraction cord

Device: knitted cotton retraction cord

Aluminum chloride gel

EXPERIMENTAL

experimental 25% aluminum chloride gel retraction

Device: aluminum chloride gel

Interventions

knitted cotton retraction cord DEVICE

00 size knitted cotton gingival displacement cord used as a control

Also known as: conventional displacement cord

Retraction cord

aluminum chloride gel DEVICE

25% Aluminum chloride gel used as an experimental intervention

Aluminum chloride gel

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age ranges from 18 to 50 years a fixed prosthesis with minimum of two abutments.
• minimum of two abutments
• Finishing line margins will be Equiogingival
• Clinically healthy gingiva and periodontium.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Armeen Fakhur

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Gingival Hemorrhage; Prosthesis Failure

Condition Hierarchy (Ancestors)

Oral Hemorrhage; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Armeen Fakhur, bds

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armeen Fakhur, bds

CONTACT

03439269593; armeenfakhur.401050@duhs.edu.pk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: In Group A, a knitted retraction cord (Ultra Pak, 0.00 mm) will be placed with a cord packer, and retraction gel applied using disposable syringe tips for 2 minutes. In Group B, gingival retraction gel with 25 % aluminum chloride (Ultradent) will be applied in the sulcus for 1-3 minutes, then rinsed with air-water spray. Impressions will be made by a one-step putty-light-body technique in metal trays, checked, disinfected, and poured with type II plaster. Casts will be coded separately. Time for placement of each system will be recorded with a stopwatch, haemorrhage control observed visually, and horizontal displacement measured by stereomicroscope and image analysis software at Dow Dental Lab.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 1, 2025
• Study Start: September 11, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)