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RecruitingNCT07255976Updated Dec 1, 2025

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

A Phase 4 interventional study of knitted cotton retraction cord and aluminum chloride gel in Gingival Bleeding, Prosthesis Failure, Dental and Tissue Injury, sponsored by Dow University of Health Sciences. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-01.

Sponsored by Dow University of Health Sciences · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 2 months after the study started (first participant enrolled Sep 2024, registered Nov 2025).
  • Started Sep 2024; still recruiting 2 years 2 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gingival Bleeding
  • Prosthesis Failure, Dental
  • Tissue Injury
03

In context

Gingival Hemorrhage

53 studies on the registry are indexed under Gingival Hemorrhage; 16 are open to participants now.

This study's planned enrollment of 66 is above the median of 54 across 49 interventional studies indexed under Gingival Hemorrhage.

Browse Gingival Hemorrhage studies →

Lead sponsor

Dow University of Health Sciences is the lead sponsor of 179 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Active comparator
    Retraction cord

    Conventionally used knitted cotton retraction cord

    Device: knitted cotton retraction cord

  • Experimental
    Aluminum chloride gel

    experimental 25% aluminum chloride gel retraction

    Device: aluminum chloride gel

Interventions

  • Deviceknitted cotton retraction cord

    00 size knitted cotton gingival displacement cord used as a control

    Also known as: conventional displacement cord

  • Devicealuminum chloride gel

    25% Aluminum chloride gel used as an experimental intervention

06

What researchers measure

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.

    Time frame: one time intervention , measure at baseline

Secondary outcomes

  1. placement time

    time for placement will be recorded with a stopwatch.

    Time frame: one time intervention , measure at baseline

  2. bleeding control

    bleeding control will be visual assist by after applying air-water spray.

    Time frame: one time intervention , measure at baseline

07

Study locations

1 of 1 sites recruiting
  • Armeen Fakhur
    Karachi, Sindh, Pakistan
    Recruiting
08

References and documents

Publications

  • Fakhur A, Kumar B, Ali J, Nasim H, Jabeen B, Lone MA. Comparison of effectiveness of gingival displacement using retraction cord and aluminum chloride gel. BMC Oral Health. 2026 Jul 21. doi: 10.1186/s12903-026-09385-1. Online ahead of print. PubMed 42481985 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07255976
Responsible party
Dr Armeen Fakhur (Principal investigator, Dow University of Health Sciences) — Principal investigator
First posted
Dec 1, 2025
Start date
Sep 11, 2024
Primary completion
Dec 15, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Dec 1, 2025

Study contacts

Armeen Fakhur, bds
Contact
armeenfakhur.401050@duhs.edu.pk
03439269593
Armeen Fakhur, bds
principal investigator · Dow University of Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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