Gingival RecessionNCT02210143
An Explorative Study To Develop A Predictive Model Based On Avascular Exposed Root Surface Area For Root Coverage
An observational study of Gingival Recession, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the reliability of the avascular root surface area as a prognostic identification criterion for gingival recessions and to compare the predictive value of the Miller classification and avascular root surface area (AERSA) calculation on the final root coverage outcomes. Read more about this study
- Who is it for?
- Ages 21 to 41 years
- Conditions the study is for
- Gingival Recession
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2011to Mar 2013
- Phase
- Observational
- 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 21 to 41 years
- All sexes
- No healthy volunteers
- Adult
Study population: Ninety one patients, 41 females and 50 males, aged between 21-41 years, with 91 isolated single gingival recessions (32 Miller I, 29 Miller II, 30 Miller III defects) located at upper and lower incisors and canines.
Who may be able to join
- Presence of isolated Miller I, II or III recession, (Miller 1985a)
- Presence of identifiable cementoenamel junction (CEJ); presence of a step ≤ 2mm at CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ,
- Full-mouth plaque score and Full-mouth bleeding score of < 15% (four sites/tooth),
- No occlusal interferences;
- Non-smokers
Who cannot join
- Tooth with a prosthetic restoration involving CEJ,
- Patients with a history of periodontitis or abscess formation,
- Presence of systemic disease or taking medications known to interfere with periodontal tissue health
- Pregnant or nursing patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University Ethics Comitee
Adana, Balcali, 01130
About this study
The aim of this study was to evaluate the reliability of the avascular root surface area as a prognostic identification criterion for gingival recessions and to compare the predictive value of the Miller classification and avascular root surface area (AERSA) calculation on the final root coverage outcomes.
- Conditions
- Gingival Recession
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AERSA-I gingival recession | The AERSA classification was developed based on 15 mm2 which is the lowest cut-off point and the group of AERSA ≤ 15 mm2 named as AERSA-I (low risk group) | |
| AERSA-II gingival recession | AERSA > 15 mm2 named as AERSA-II (high risk group). | |
| Miller gingival recession | Gingival recessions classified according to Miller |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete root coverage
Measured: 6 months
Secondary outcomes (1)
mean root coverage
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startFeb 2011
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Ozcelik, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210143
- Sponsor's protocol ID
- CUDHF-2011-8-6
- Status last verified
- Aug 2014
- First submitted
- 5 Aug 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Study To Develop A Predictive Model Based On Avascular Exposed Root Surface Area For Root Coverage
- ClinicalTrials.gov ID
- NCT02210143
- Acronym / sponsor ID
- CUDHF-2011-8-6
- Conditions
- Gingival Recession
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Mar 2013 (actual)
- First posted
- 6 Aug 2014 (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.
The aim of this study was to evaluate the reliability of the avascular root surface area as a prognostic identification criterion for gingival recessions and to compare the predictive value of the Miller classification and avascular root surface area (AERSA) calculation on the final root coverage outcomes.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AERSA-I gingival recession | – | –The AERSA classification was developed based on 15 mm2 which is the lowest cut-off point and the group of AERSA ≤ 15 mm2 named as AERSA-I (low risk group) |
| AERSA-II gingival recession | – | –AERSA > 15 mm2 named as AERSA-II (high risk group). |
| Miller gingival recession | – | –Gingival recessions classified according to Miller |
Who may qualify
- Ages
- 21 to 41 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Ninety one patients, 41 females and 50 males, aged between 21-41 years, with 91 isolated single gingival recessions (32 Miller I, 29 Miller II, 30 Miller III defects) located at upper and lower incisors and canines.
Key inclusion criteria (5 listed)
- Presence of isolated Miller I, II or III recession, (Miller 1985a)
- Presence of identifiable cementoenamel junction (CEJ); presence of a step ≤ 2mm at CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ,
- Full-mouth plaque score and Full-mouth bleeding score of < 15% (four sites/tooth),
- No occlusal interferences;
- Non-smokers
Key exclusion criteria (4 listed)
- Tooth with a prosthetic restoration involving CEJ,
- Patients with a history of periodontitis or abscess formation,
- Presence of systemic disease or taking medications known to interfere with periodontal tissue health
- Pregnant or nursing patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete root coverage
Time frame: 6 months
1 secondary outcome
mean root coverage
Time frame: 6 months
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 6 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Recession, run by Cukurova University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 6 Aug 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 Turkey (Türkiye). 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?
Complete root coverage (time frame: 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 6 Aug 2014.