Gingival HemorrhageretractionNCT03892109
Evaluation of Different Gingival Retraction Systems on Gingival Displacement and Periodontal Health
A study testing No Cord impression material, cord and Gingitrac in people with Gingival Hemorrhage, run by Cairo University at 1 site in Egypt.
Trial summary
The interrelationship of restorative dentistry and periodontics is a dynamic one. The interactions between restorative dentistry and periodontal health have been well-documented both clinically and histologically. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gingival Hemorrhage
- What is being tested?
- No Cord impression material, cord and Gingitrac
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- forty patients whose ages more than 18 years were selected requiring fixed prosthesis with minimum of two abutments.
- Clinically and radiographically healthy gingiva and periodontium around the abutments.
- Abutment teeth of normal size and contour (no developmental anomaly or regressive age changes).
Who cannot join
- Age <18 years.
- Gingival and periodontal disease.
- Uncontrolled diabetes, hypertension, hyperthyroidism and other cardiovascular disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Comparative Evaluation of Different Retraction Systems in Gingival Displacement and Their Influence on Periodontal Health
The interrelationship of restorative dentistry and periodontics is a dynamic one. The interactions between restorative dentistry and periodontal health have been well-documented both clinically and histologically.
The interplay between periodontics and restorative dentistry is present at many fronts, including location of restorative margins, alloy sensitivity, crown contours, and response of the gingival tissues to restorative preparations.
Read more
Periodontal tissues form the foundation for proper esthetics, function, and comfort of the dentition, as well as the periodontal health at the restorative gingival interface consider as prerequisite for successful outcome.
Success of fixed prosthodontics restorations is largely dependent upon the long term health and stability of the surrounding periodontal structures.
The purpose of the present study was to evaluate the clinical efficacy of 4 new gingival retraction systems; traxodent, Gingitrac, Nocord, and cord , on the basis of the time taken for placement, hemorrhage control ,the amount of horizontal gingival displacement and periodontal parameter (PI, GI, CAL and PD).
Read the detailed description
The interplay between periodontics and restorative dentistry is present at many fronts, including location of restorative margins, alloy sensitivity, crown contours, and response of the gingival tissues to restorative preparations.
And from fixed prothodontic point of view there are several factors affect the success and durability of restorations. In general, the type of impression making, setting accuracy, material flow, temperature, humidity, mixing, disinfection and pouring time have effects on the final accuracy of the indirect restorations. Supra-gingival margins are effective in periodontal health maintenance, but do not provide optimal aesthetics.
The primary factor in defective record of marginal details is due to the inefficacy of the gingival displacement technique.
Traditionally, procedures for soft-tissue management and isolation are classified into three main approaches: Mechanical, chemical or surgical.
material and method:-
40 subjects were selected requiring fixed prosthesis according to inclusion and exclusion criteria.
The 4 gingival retraction systems were used on the prepared abutments randomly. The time taken for placement of each retraction system was recorded.
Hemorrhage score will be recoreded. The horizontal retraction was measured on polyether impressions made before the retraction and after retraction using stereoscope.
The periodontal parameter (PI, GI, CAL and PD) will be recorded pre-operative, 1 day post-operative and 7 days post-operative.
- Conditions
- Gingival Hemorrhage
- Being tested
- No Cord impression material, cord, Gingitrac
- Medical subject headings
- Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Cord impression materialOther
the no cord self- retracting impression material placed directly in the tray
cordDevice
Cords were placed in the gingival sulcus with use of a cord packer, and left in situ for 10 min before making the impression. None of the retraction cords were immersed in any solution or medicaments prior to insertion.
GingitracOther
packed into the sulcus
| Study group | Role | What they receive |
|---|---|---|
| Gingitrac | Active comparator | The gingitrac cartridge was attached to the automixing gun and then the mixing syringe with intraoral tip was placed into the gingival sulcus and gingival retraction material was applied all around the selected abutment. After injecting the retraction material ,the corresponding comprecap was placed on to the abutment to push the material deep into the gingival sulcus. After 4 min, the comprecap with the set retraction material attached to it was removed from the patient mouth. Receives: Other: No Cord impression material; Device: cord; Other: Gingitrac |
| traxodent | Active comparator | The traxodent cartridge was attached to the automixing gun and then the mixing syringe with intraoral tip was placed into the gingival sulcus and gingival retraction material was applied all around the tooth. After injecting the retraction material ,the corresponding comprecap was placed on to the abutment to push the material deep into the gingival sulcus. After 4 min, the comprecap with the set retraction material attached to it was removed from the patient mouth. Receives: Other: No Cord impression material; Device: cord; Other: Gingitrac |
| Ultrapk cord | Experimental | the cord packed into the gingival sulcus around the tooth Receives: Other: No Cord impression material; Device: cord; Other: Gingitrac |
| nocord | Placebo comparator | used directly in the tray Receives: Other: No Cord impression material; Device: cord; Other: Gingitrac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of placement
time taken for placement of each retraction system was recorded during application
Measured: the time recorded in seconds (from 1 second to 2 minutes)
Hemorrhage score
the amount of bleedingbleeding on probing scoring as 0, 1, and 2 (0 - no bleeding, 1 - bleeding controlled within 1 minute, bleeding, 2 - bleeding not controlled within 1 minute)
Measured: from base line to 1 day
Secondary outcomes (4)
Horizontal gingival displacement
The horizontal displacement was measured on polyether impressions made before the retraction and after retraction using steroscope.
Measured: from baseline to 24 hours
Gingival index
according to gingival index, scored as 0,1,2 and 3( 0 = no inflamation and no gingival bleeding, 1= mild redness of the gingiva, no bleeding, 2=moderate inflammation and redness of the gingiva, edema and bleeding,3= marked redness, edema, ulceration and severe bleeding).
Measured: at baseline ,after 1 day and after seven days
Pocket depth
according to pocket depth The probe was held with a light grasp and pointed towards the apex buccally while being parallel to the long axis of the tooth. Each measurement was rounded to the lowest whole millimetre.
according to pocket depth The probe was held with a light grasp and pointed towards the apex buccally while being parallel to the long axis of the tooth. Each measurement was rounded to the lowest whole millimetre.
Measured: at baseline, after 1 day and after seven days
Plaque index
according to the plaque index, plaque index scoring as 0, 1, 2, and 3 (0 - no plaque and 1 - a film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or using the probe on the tooth surface, 2 - moderate accumulation of soft deposits within the gingival pocket or the tooth and gingival margin which can be seen with the naked eye, and 3 - abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin).
Measured: at baseline, after 1 day and after seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Feb 2019
- Primary completion1 Feb 2020 (estimated)
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival HemorrhageStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asma Serag, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892109
- Sponsor's protocol ID
- 2000019
- Acronym
- retraction
- Status last verified
- Dec 2019
- First submitted
- 20 Mar 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparative Evaluation of Different Retraction Systems in Gingival Displacement and Their Influence on Periodontal Health
- ClinicalTrials.gov ID
- NCT03892109
- Acronym / sponsor ID
- retraction / 2000019
- Conditions
- Gingival Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 27 Mar 2019 (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.
The interrelationship of restorative dentistry and periodontics is a dynamic one. The interactions between restorative dentistry and periodontal health have been well-documented both clinically and histologically.
The interplay between periodontics and restorative dentistry is present at many fronts, including location of restorative margins, alloy sensitivity, crown contours, and response of the gingival tissues to restorative preparations.
Periodontal tissues form the foundation for proper esthetics, function, and comfort of the dentition, as well as the periodontal health at the restorative gingival interface consider as prerequisite for successful outcome.
Success of fixed prosthodontics restorations is largely dependent upon the long term health and stability of the surrounding periodontal structures.
The purpose of the present study was to evaluate the clinical efficacy of 4 new gingival retraction systems; traxodent, Gingitrac, Nocord, and cord , on the basis of the time taken for placement, hemorrhage control ,the amount of horizontal gingival displacement and periodontal parameter (PI, GI, CAL and PD).
Detailed description
The interplay between periodontics and restorative dentistry is present at many fronts, including location of restorative margins, alloy sensitivity, crown contours, and response of the gingival tissues to restorative preparations.
And from fixed prothodontic point of view there are several factors affect the success and durability of restorations. In general, the type of impression making, setting accuracy, material flow, temperature, humidity, mixing, disinfection and pouring time have effects on the final accuracy of the indirect restorations. Supra-gingival margins are effective in periodontal health maintenance, but do not provide optimal aesthetics.
The primary factor in defective record of marginal details is due to the inefficacy of the gingival displacement technique.
Traditionally, procedures for soft-tissue management and isolation are classified into three main approaches: Mechanical, chemical or surgical.
material and method:-
40 subjects were selected requiring fixed prosthesis according to inclusion and exclusion criteria.
The 4 gingival retraction systems were used on the prepared abutments randomly. The time taken for placement of each retraction system was recorded.
Hemorrhage score will be recoreded. The horizontal retraction was measured on polyether impressions made before the retraction and after retraction using stereoscope.
The periodontal parameter (PI, GI, CAL and PD) will be recorded pre-operative, 1 day post-operative and 7 days post-operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Gingitrac | Active comparator | Other: No Cord impression material, Device: cord, Other: GingitracThe gingitrac cartridge was attached to the automixing gun and then the mixing syringe with intraoral tip was placed into the gingival sulcus and gingival retraction material was applied all around the selected abutment. After injecting the retraction material ,the corresponding comprecap was placed on to the abutment to push the material deep into the gingival sulcus. After 4 min, the comprecap with the set retraction material attached to it was removed from the patient mouth. |
| traxodent | Active comparator | Other: No Cord impression material, Device: cord, Other: GingitracThe traxodent cartridge was attached to the automixing gun and then the mixing syringe with intraoral tip was placed into the gingival sulcus and gingival retraction material was applied all around the tooth. After injecting the retraction material ,the corresponding comprecap was placed on to the abutment to push the material deep into the gingival sulcus. After 4 min, the comprecap with the set retraction material attached to it was removed from the patient mouth. |
| Ultrapk cord | Experimental | Other: No Cord impression material, Device: cord, Other: Gingitracthe cord packed into the gingival sulcus around the tooth |
| nocord | Placebo comparator | Other: No Cord impression material, Device: cord, Other: Gingitracused directly in the tray |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- forty patients whose ages more than 18 years were selected requiring fixed prosthesis with minimum of two abutments.
- Clinically and radiographically healthy gingiva and periodontium around the abutments.
- Abutment teeth of normal size and contour (no developmental anomaly or regressive age changes).
Key exclusion criteria (3 listed)
- Age <18 years.
- Gingival and periodontal disease.
- Uncontrolled diabetes, hypertension, hyperthyroidism and other cardiovascular disorders.
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 |
|---|---|---|
| No Cord impression materialthe no cord self- retracting impression material placed directly in the tray | Other | Gingitrac, Ultrapk cord, nocord, traxodent |
| cordCords were placed in the gingival sulcus with use of a cord packer, and left in situ for 10 min before making the impression. None of the retraction cords were immersed in any solution or medicaments prior to insertion. | Device | Gingitrac, Ultrapk cord, nocord, traxodent |
| Gingitracpacked into the sulcus | Other | Gingitrac, Ultrapk cord, nocord, traxodent |
Primary outcome
Time of placement
Time frame: the time recorded in seconds (from 1 second to 2 minutes)
time taken for placement of each retraction system was recorded during application
Hemorrhage score
Time frame: from base line to 1 day
the amount of bleedingbleeding on probing scoring as 0, 1, and 2 (0 - no bleeding, 1 - bleeding controlled within 1 minute, bleeding, 2 - bleeding not controlled within 1 minute)
4 secondary outcomes
Horizontal gingival displacement
Time frame: from baseline to 24 hours
Gingival index
Time frame: at baseline ,after 1 day and after seven days
Pocket depth
Time frame: at baseline, after 1 day and after seven days
Plaque index
Time frame: at baseline, after 1 day and after seven days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Cord impression material, cord and Gingitrac in people with Gingival Hemorrhage, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Jan 2020. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact asma m serag, lecturer (01006513595, sou_201085@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of placement (time frame: the time recorded in seconds (from 1 second to 2 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2020.