Gingival BleedingPhase 4NCT07255976
Comparison of Effectiveness of Gingival Displacement Using Retraction Cord and Aluminum Chloride Gel
A Phase 4 study testing knitted cotton retraction cord and aluminum chloride gel in people with Gingival Bleeding and Prosthesis Failure, Dental, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Bleeding, Prosthesis Failure, Dental, Tissue Injury
- What is being tested?
- knitted cotton retraction cord and aluminum chloride gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Sep 2024to 30 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Armeen Fakhur
Karachi, Sindh
Armeen Fakhur, bds, 03439269593, armeenfakhur.401050@duhs.edu.pk
About this study
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.
- Conditions
- Gingival Bleeding, Prosthesis Failure, Dental, Tissue Injury
- Being tested
- knitted cotton retraction cord, aluminum chloride gel
- Medical subject headings
- Gingival Hemorrhage, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knitted cotton retraction cordDevice
Also called conventional displacement cord
00 size knitted cotton gingival displacement cord used as a control
aluminum chloride gelDevice
25% Aluminum chloride gel used as an experimental intervention
| Study group | Role | What they receive |
|---|---|---|
| Retraction cord | Active comparator | Conventionally used knitted cotton retraction cord Receives: Device: knitted cotton retraction cord |
| Aluminum chloride gel | Experimental | experimental 25% aluminum chloride gel retraction Receives: Device: aluminum chloride gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one time intervention , measure at baseline
Secondary outcomes (2)
placement time
time for placement will be recorded with a stopwatch.
Measured: one time intervention , measure at baseline
bleeding control
bleeding control will be visual assist by after applying air-water spray.
Measured: one time intervention , measure at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start11 Sep 2024
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Armeen Fakhur, Dow University of Health Sciences
- Investigators
- Armeen Fakhur, bds, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255976
- Sponsor's protocol ID
- Dr Armeen Fakhur
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Gingival Displacement Using Retraction Cord and Aluminum Chloride Gel
- ClinicalTrials.gov ID
- NCT07255976
- Acronym / sponsor ID
- Dr Armeen Fakhur
- Conditions
- Gingival Bleeding, Prosthesis Failure, Dental, Tissue Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Retraction cord | Active comparator | Device: knitted cotton retraction cordConventionally used knitted cotton retraction cord |
| Aluminum chloride gel | Experimental | Device: aluminum chloride gelexperimental 25% aluminum chloride gel retraction |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| knitted cotton retraction cordAlso: conventional displacement cord00 size knitted cotton gingival displacement cord used as a control | Device | Retraction cord |
| aluminum chloride gel25% Aluminum chloride gel used as an experimental intervention | Device | Aluminum chloride gel |
Primary outcome
horizontal gingival displacement
Time frame: one time intervention , measure at baseline
Horizontal displacement will be analyzed on casts using stereomicroscope imaging and image analysis software at Dow Dental Lab. and measurment in micron meter unit.
2 secondary outcomes
placement time
Time frame: one time intervention , measure at baseline
bleeding control
Time frame: one time intervention , measure at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Derived from this study: PubMed 42481985Fakhur 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Armeen Fakhur, bds principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing knitted cotton retraction cord and aluminum chloride gel in people with Gingival Bleeding and Prosthesis Failure, Dental, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armeen Fakhur, bds (03439269593, armeenfakhur.401050@duhs.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
horizontal gingival displacement (time frame: one time intervention , measure at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07255976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.