Gingival DisplacementNCT06132815
The Efficacy of Different Gingival Displacement Methods Before Definitive Digital Impression
A study testing Laser troughing, Retraction cord and astringent and Cordless retraction paste with astringent in people with Gingival Displacement, run by Alexandria University at 1 site in Egypt.
Trial summary
This study aims to evaluate and compare the efficacy of four methods in achieving vertical and horizontal gingival tissue displacement to be captured by optical digital impression. Moreover, the effect of the gingival displacement methods on the periodontal tissues around the final restoration will be assessed. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Gingival Displacement
- What is being tested?
- Laser troughing, Retraction cord and astringent and Cordless retraction paste with astringent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 30 Aug 2023
- 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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients having normal occlusion.
- Good oral hygiene with no signs of periapical pathology or periodontal disease (plaque index score ≤10).
- Clinically and radiographically healthy gingiva and periodontium around the abutments with no evidence of attachment loss.
- Thick gingival biotype (determination using color coded probe).
- Patient having natural teeth as opposing dentition.
- Gingival sulcus of the abutment teeth (≤ 3mm).
- Adequate abutment tooth length for retention without deep subgingival extension (not more than 0.5mm)
Who cannot join
- Pregnancy, which prevents the use of diagnostic x-rays.
- Parafunctional habits.
- Mobility of abutment teeth.
- Gingival Recession
- Patient presenting allergy to materials being used.
- Smoking.
- Medical history that could affect their periodontal condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Different Gingival Displacement Methods Before Definitive Digital Impression: A Randomized Controlled Clinical Trial
This study aims to evaluate and compare the efficacy of four methods in achieving vertical and horizontal gingival tissue displacement to be captured by optical digital impression. Moreover, the effect of the gingival displacement methods on the periodontal tissues around the final restoration will be assessed.
- Conditions
- Gingival Displacement
- Being tested
- Laser troughing, Retraction cord and astringent, Cordless retraction paste with astringent, Cordless retraction paste without astringent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser troughingDevice
Laser troughing will be carried out by passing laser optic fiber in contact mode along the gingival sulcus. Laser energy will be delivered with a wavelength of 980nm and power of 0.8W, in continuous mode. Laser tip will be inserted 1mm into the gingival sulcus, to facilitate an accurate recording of finish line
Retraction cord and astringentOther
Partial isolation of the tooth with cotton rolls and saliva ejector will be performed. Appropriate size of retraction cord will be soaked in astringent for 5 mins. Then packing of the cord will be started from the mesial interproximal area by gently packing into the sulcus with the gingival cord packer instrument using the single cord technique. Retraction cord will be kept in place for 5 minutes. Cord will be removed immediately before the start of the intraoral scan
Cordless retraction paste with astringentOther
The cordless paste with astringent will be injected gently into the sulcus, leaning on the tooth at the point of the cervical limit and not on the gingiva, the cannula will remain parallel to the axis of the tooth to exert optimal pressure. Then it will removed after 5 mins with copiously irrigated water until no traces of the materials left.
Cordless retraction paste without astringentOther
The cordless paste without astringent 10 will be injected into the sulcus of the gingiva. The suitable size of Comprecap will be held on the abutment to push the material deep into the sulcus of the gingiva, and the participants will be informed to bite over it for a period of 3 to 5 minutes. After 5 minutes, the comprecap with the set retraction material attached to it, will be removed from the patient mouth.
| Study group | Role | What they receive |
|---|---|---|
| Laser troughing | Experimental | Not described Receives: Device: Laser troughing |
| Retraction cord and astringent | Experimental | Not described Receives: Other: Retraction cord and astringent |
| Cordless retraction paste with astringent | Experimental | Not described Receives: Other: Cordless retraction paste with astringent |
| Cordless retraction paste without astringent | Active comparator | Not described Receives: Other: Cordless retraction paste without astringent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal displacement measurement
All measurements were obtained from the definitive digital impression by using dental intraoral scanner software. Horizontal displacement was measured as the distance from the most prominent point of the crest of the marginal gingiva to the finish line in the same crowns section (in the same plane).
Measured: up to one month
Vertical Displacement measurement
All measurements were obtained from the definitive digital impression by using dental intraoral scanner software. Vertical displacement will be measured as the distance from the most prominent point of the finish line to the deepest point of gingival sulcus.
Measured: up to one month
Secondary outcomes (3)
Dental plaque measurement
Using the plaque index of Silness and Loe. Each tooth will be scored from 0-3 according to the amount of plaque accumulation.
0: No plaque in the gingival area.
- A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
- Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
- Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Measured: up to one month
Gingival inflammation measurement
Using the gingival index of Silness and Loe. Each tooth will be scored from 0-3 according to the degree of gingival inflammation.
0: Normal gingiva
- Mild inflammation - slight change in color, slight oedema. No bleeding on probing
- Moderate inflammation-redness, oedema and glazing. Bleeding on probing
- Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding
Measured: up to one month
Gingival Height loss measurement
Complete arch maxillary digital impressions (postoperative scans) will be made for each patient by using intraoral scanner after cementation of the crowns. The postoperative scans will be superimposed by the pre-operative scan. A cross sectional line will be drawn in the middle of the superimposed scans and the measurements will be done at 2 points (midbuccal and midlingual). The distance from the gingival margin of the preoperative scan to that of one postoperative scan will be considered gingival height loss at the scan's timepoint
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start1 Jun 2022
- Primary completion1 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival DisplacementStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elashry, Alexandria University
- Investigators
- Mohamed F Elashry, MSc, Principal investigator, Alexandria UniversitySanaa Hussein, PhD, Study chair, Alexandria UniversityIhab Hammad, PhD, Study chair, Alexandria UniversityRania Fahmy, PhD, Study chair, Alexandria UniversityIslam M Abdel Raheem, PhD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132815
- Sponsor's protocol ID
- #2/2022
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Different Gingival Displacement Methods Before Definitive Digital Impression: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06132815
- Acronym / sponsor ID
- #2/2022
- Conditions
- Gingival Displacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 15 Nov 2023 (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 evaluate and compare the efficacy of four methods in achieving vertical and horizontal gingival tissue displacement to be captured by optical digital impression. Moreover, the effect of the gingival displacement methods on the periodontal tissues around the final restoration will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Laser troughing | Experimental | Device: Laser troughing |
| Retraction cord and astringent | Experimental | Other: Retraction cord and astringent |
| Cordless retraction paste with astringent | Experimental | Other: Cordless retraction paste with astringent |
| Cordless retraction paste without astringent | Active comparator | Other: Cordless retraction paste without astringent |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients having normal occlusion.
- Good oral hygiene with no signs of periapical pathology or periodontal disease (plaque index score ≤10).
- Clinically and radiographically healthy gingiva and periodontium around the abutments with no evidence of attachment loss.
- Thick gingival biotype (determination using color coded probe).
- Patient having natural teeth as opposing dentition.
Key exclusion criteria (7 listed)
- Pregnancy, which prevents the use of diagnostic x-rays.
- Parafunctional habits.
- Mobility of abutment teeth.
- Gingival Recession
- Patient presenting allergy to materials being used.
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 |
|---|---|---|
| Laser troughingLaser troughing will be carried out by passing laser optic fiber in contact mode along the gingival sulcus. Laser energy will be delivered with a wavelength of 980nm and power of 0.8W, in continuous mode. Laser tip will be inserted 1mm into the gingival sulcus, to facilitate an accurate recording of finish line | Device | Laser troughing |
| Retraction cord and astringentPartial isolation of the tooth with cotton rolls and saliva ejector will be performed. Appropriate size of retraction cord will be soaked in astringent for 5 mins. Then packing of the cord will be started from the mesial interproximal area by gently packing into the sulcus with the gingival cord packer instrument using the single cord technique. Retraction cord will be kept in place for 5 minutes. Cord will be removed immediately before the start of the intraoral scan | Other | Retraction cord and astringent |
| Cordless retraction paste with astringentThe cordless paste with astringent will be injected gently into the sulcus, leaning on the tooth at the point of the cervical limit and not on the gingiva, the cannula will remain parallel to the axis of the tooth to exert optimal pressure. Then it will removed after 5 mins with copiously irrigated water until no traces of the materials left. | Other | Cordless retraction paste with astringent |
| Cordless retraction paste without astringentThe cordless paste without astringent 10 will be injected into the sulcus of the gingiva. The suitable size of Comprecap will be held on the abutment to push the material deep into the sulcus of the gingiva, and the participants will be informed to bite over it for a period of 3 to 5 minutes. After 5 minutes, the comprecap with the set retraction material attached to it, will be removed from the patient mouth. | Other | Cordless retraction paste without astringent |
Primary outcome
Horizontal displacement measurement
Time frame: up to one month
All measurements were obtained from the definitive digital impression by using dental intraoral scanner software. Horizontal displacement was measured as the distance from the most prominent point of the crest of the marginal gingiva to the finish line in the same crowns section (in the same plane).
Vertical Displacement measurement
Time frame: up to one month
All measurements were obtained from the definitive digital impression by using dental intraoral scanner software. Vertical displacement will be measured as the distance from the most prominent point of the finish line to the deepest point of gingival sulcus.
3 secondary outcomes
Dental plaque measurement
Time frame: up to one month
Gingival inflammation measurement
Time frame: up to one month
Gingival Height loss measurement
Time frame: up to one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
Related trials for Gingival Displacement
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Recruiting
The Use of Coronary Displaced Flap and Deepithelialized Free Graft in the Treatment of Multiple Gingival Recessions
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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.
Mohamed F Elashry, MSc principal investigator
Alexandria University
Sanaa Hussein, PhD study chair
Alexandria University
Ihab Hammad, PhD study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser troughing, Retraction cord and astringent and Cordless retraction paste with astringent in people with Gingival Displacement, run by Alexandria 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 15 Nov 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal displacement measurement (time frame: up to one month). 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 15 Nov 2023.