Poor Aesthetic of Existing Restoration of ToothPhase 1NCT01848496
Clinical Trial of Two Techniques for Gingival Displacement
A Phase 1 study testing Gingival displacement in people with Poor Aesthetic of Existing Restoration of Tooth, run by Maximiliano Sergio Cenci at 1 site in Brazil.
Trial summary
Regardless of the selected technique for dental impression, gingival displacement is an essential procedure specially when making impressions of subgingival finishing lines, because a moisture-free sulcus is a requirement for an effective impression. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Poor Aesthetic of Existing Restoration of Tooth
- What is being tested?
- Gingival displacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Mar 2013
- Phase
- Phase 1
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good general and dental health
- at least two anterior teeth with an indication of prosthetic dental crown
Who cannot join
- smoking habits
- systemic diseases
- pregnant
- had not consumed antibiotics or anti-inflammatory drugs in the last 60 days
- the selected teeth must have good periodontal health characterized by regular gingival margin with at least 2 mm of attached gingiva, non-fibrotic gingival tissue, no marginal recession, probing depth ≤ 3 mm, no evidence of significant loss of bone insertion and present no visible plaque and gingival bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Randomized Clinical Trial of Two Techniques for Gingival Displacement
Regardless of the selected technique for dental impression, gingival displacement is an essential procedure specially when making impressions of subgingival finishing lines, because a moisture-free sulcus is a requirement for an effective impression.
The objective of this randomized clinical study is to evaluate the efficacy of the conventional and cordless gingival displacement (GD) techniques.
Read the detailed description
On conventional technique we normally use a cord for gingival displacement. On the other hand, on cordless technique do not require this need.
- Being tested
- Gingival displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival displacementProcedure or surgery
Gingival displacement is a dental procedure that allows exposure of the finishing line of a dental cavity in order to produce a well-adapted restoration.
| Study group | Role | What they receive |
|---|---|---|
| Cordless technique | Experimental | This technique does not employ a gingival cord to obtain gingival displacement. Receives: Procedure: Gingival displacement |
| Conventional technique | Active comparator | This technique employ a gingival cord to obtain gingival displacement. Receives: Procedure: Gingival displacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukins concentration on gingival crevicular fluid
Measured: Before and 1 day after gilgival displacement
Secondary outcomes (1)
Periodontal indices
Periodontal indices (attachment level, gingival bleeding and plaque index) were evaluated before and after gingival displacement by the both techniques.
Measured: Before, 1 day after and 10 day after gingival displacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Poor Aesthetic of Existing Restoration of ToothStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maximiliano Sergio Cenci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
- Investigators
- Hugo R Sarmento, MSc, Study chair, Federal University of PelotasFernanda Faot, PhD, Principal investigator, Federal University of PelotasFábio RM Leite, PhD, Study director, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848496
- Sponsor's protocol ID
- PPGO0015
- Status last verified
- May 2013
- First submitted
- 25 Apr 2013
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Al Hamad KQ, Azar WZ, Alwaeli HA, Said KN. A clinical study on the effects of cordless and conventional retraction techniques on the gingival and periodontal health. J Clin Periodontol. 2008 Dec;35(12):1053-8. doi: 10.1111/j.1600-051X.2008.01335.x.
PubMed 19040582Passariello C, Puttini M, Virga A, Gigola P. Microbiological and host factors are involved in promoting the periodontal failure of metaloceramic crowns. Clin Oral Investig. 2012 Jun;16(3):987-95. doi: 10.1007/s00784-011-0585-0. Epub 2011 Jul 1.
PubMed 21720749Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
PubMed 1058834
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Clinical Trial of Two Techniques for Gingival Displacement
- ClinicalTrials.gov ID
- NCT01848496
- Acronym / sponsor ID
- PPGO0015
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Maximiliano Sergio CenciUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 7 May 2013 (estimated)
- 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.
Regardless of the selected technique for dental impression, gingival displacement is an essential procedure specially when making impressions of subgingival finishing lines, because a moisture-free sulcus is a requirement for an effective impression.
The objective of this randomized clinical study is to evaluate the efficacy of the conventional and cordless gingival displacement (GD) techniques.
Detailed description
On conventional technique we normally use a cord for gingival displacement. On the other hand, on cordless technique do not require this need.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cordless technique | Experimental | Procedure: Gingival displacementThis technique does not employ a gingival cord to obtain gingival displacement. |
| Conventional technique | Active comparator | Procedure: Gingival displacementThis technique employ a gingival cord to obtain gingival displacement. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- good general and dental health
- at least two anterior teeth with an indication of prosthetic dental crown
Key exclusion criteria (5 listed)
- smoking habits
- systemic diseases
- pregnant
- had not consumed antibiotics or anti-inflammatory drugs in the last 60 days
- the selected teeth must have good periodontal health characterized by regular gingival margin with at least 2 mm of attached gingiva, non-fibrotic gingival tissue, no marginal recession, probing depth ≤ 3 mm, no evidence of significant loss of bone insertion and present no visible plaque and gingival bleeding
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 |
|---|---|---|
| Gingival displacementGingival displacement is a dental procedure that allows exposure of the finishing line of a dental cavity in order to produce a well-adapted restoration. | Procedure or surgery | Conventional technique, Cordless technique |
Primary outcome
Interleukins concentration on gingival crevicular fluid
Time frame: Before and 1 day after gilgival displacement
1 secondary outcome
Periodontal indices
Time frame: Before, 1 day after and 10 day after gingival displacement
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 7 May 2013.
- Background: PubMed 19040582Al Hamad KQ, Azar WZ, Alwaeli HA, Said KN. A clinical study on the effects of cordless and conventional retraction techniques on the gingival and periodontal health. J Clin Periodontol. 2008 Dec;35(12):1053-8. doi: 10.1111/j.1600-051X.2008.01335.x.
- Background: PubMed 21720749Passariello C, Puttini M, Virga A, Gigola P. Microbiological and host factors are involved in promoting the periodontal failure of metaloceramic crowns. Clin Oral Investig. 2012 Jun;16(3):987-95. doi: 10.1007/s00784-011-0585-0. Epub 2011 Jul 1.
- Background: PubMed 1058834Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
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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.
Hugo R Sarmento, MSc study chair
Federal University of Pelotas
Fernanda Faot, PhD principal investigator
Federal University of Pelotas
Fábio RM Leite, PhD study director
Federal University of Pelotas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gingival displacement in people with Poor Aesthetic of Existing Restoration of Tooth, run by Maximiliano Sergio Cenci at 1 site in Brazil.
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 2 inclusion and 5 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 7 May 2013. 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 Brazil. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Interleukins concentration on gingival crevicular fluid (time frame: Before and 1 day after gilgival displacement). 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 NCT01848496, which also lists 3 linked publications.
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 7 May 2013.