Gingival CleftsNCT01402323
Gingival Clefts and Orthodontic Movement
A study testing time point of tooth extraction in people with Gingival Clefts and Extraction Socket, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Clefts or invaginations of the gingival tissue are a frequent finding during orthodontic space closure after extraction of a tooth. They occur in about 35% of the cases. Increased risk of developing a gingival cleft is given in the mandibular arch. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Clefts, Extraction Socket, Orthodontic Movement
- What is being tested?
- time point of tooth extraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2011to Dec 2015
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- extraction of both molars or premolars in the upper or lower jaw and orthodontic space closure
Who cannot join
- periodontal status not allowing orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Bernhard Gottlieb School of Dentistry, Medical University of Vienna
Vienna, 1090
Kristina Bertl, DMD, +43 664 51515194, kristina.bertl@meduniwien.ac.at
About this study
Official title: A Prospective Split-mouth Designed Study on the Incidence of Gingival Clefts During Orthodontic Space Closure Into Recent or Healed Extraction Sockets.
Clefts or invaginations of the gingival tissue are a frequent finding during orthodontic space closure after extraction of a tooth. They occur in about 35% of the cases. Increased risk of developing a gingival cleft is given in the mandibular arch. A gingival invagination impairs aesthetics, orthodontic treatment and periodontal health. The aim of this prospective split-mouth designed observer blinded study is to evaluate possible differences between tooth movement in recent or in healed extraction sockets on incidence of gingival clefts. We hypothesize, that similar to the results originated from an animal study immediate movement in extraction sockets reduces incidence of gingival clefts during orthodontic space closure.
- Conditions
- Gingival Clefts, Extraction Socket, Orthodontic Movement
- Being tested
- time point of tooth extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
time point of tooth extractionOther
| Study group | Role | What they receive |
|---|---|---|
| early or late tooth extraction | Other | Not described Receives: Other: time point of tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of gingival clefts
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival CleftsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402323
- Sponsor's protocol ID
- EK Nr 105/2011
- Status last verified
- Jul 2011
- First submitted
- 25 Jul 2011
- Last updated
- 20 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Split-mouth Designed Study on the Incidence of Gingival Clefts During Orthodontic Space Closure Into Recent or Healed Extraction Sockets.
- ClinicalTrials.gov ID
- NCT01402323
- Acronym / sponsor ID
- EK Nr 105/2011
- Conditions
- Gingival Clefts, Extraction Socket, Orthodontic Movement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2015 (estimated)
- First posted
- 26 Jul 2011 (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.
Clefts or invaginations of the gingival tissue are a frequent finding during orthodontic space closure after extraction of a tooth. They occur in about 35% of the cases. Increased risk of developing a gingival cleft is given in the mandibular arch. A gingival invagination impairs aesthetics, orthodontic treatment and periodontal health. The aim of this prospective split-mouth designed observer blinded study is to evaluate possible differences between tooth movement in recent or in healed extraction sockets on incidence of gingival clefts. We hypothesize, that similar to the results originated from an animal study immediate movement in extraction sockets reduces incidence of gingival clefts during orthodontic space closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| early or late tooth extraction | Other | Other: time point of tooth extraction |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- extraction of both molars or premolars in the upper or lower jaw and orthodontic space closure
Key exclusion criteria (1 listed)
- periodontal status not allowing orthodontic treatment
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 |
|---|---|---|
| time point of tooth extraction | Other | early or late tooth extraction |
Primary outcome
incidence of gingival clefts
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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 time point of tooth extraction in people with Gingival Clefts and Extraction Socket, run by Medical University of Vienna at 1 site in Austria.
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 1 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: status not confirmed, as of the sponsor's last update on 20 May 2014. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristina Bertl, DMD (+43 664 5151194, kristina.bertl@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of gingival clefts (time frame: up to 6 months). 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 20 May 2014.