Gingival RecessionsNCT02479633
Predetermination for Gingival Recession
A study testing Coronally advanced flap with connective tissue graft in people with Gingival Recessions, run by Cukurova University.
Trial summary
Background: The aim of present clinical study was to evaluate the predictive values of baseline inter-dental papilla height (IPH), avascular exposed root surface area (AERSA) and inter-dental clinical attachment loss (CAL) measurements on complete root coverage (CRC) of single gingival recession (GR) defects treated… Read more about this study
- Who is it for?
- Ages 20 to 42 years
- Conditions the study is for
- Gingival Recessions
- What is being tested?
- Coronally advanced flap with connective tissue graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jun 2014
- 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 20 to 42 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of isolated RT1 and RT2 class gingival recessions with an AERSA ˃9mm2 on upper and lower incisors,
- Presence of identifiable cemento-enamel junction (CEJ); presence of a step ≤1mm at the 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%,
- No occlusal interferences;
Who cannot join
- Patients with a history of periodontitis or abscess formation,
- Mucogingival or periodontal surgery at the experimental site in the last 1 year,
- Presence of systemic disease or taking medication known to interfere with periodontal tissue health,
- Smokers, pregnant patients.
About this study
Official title: Predetermınatıon of Root Coverage for Recessıons Treated wıth Coronally Advanced Flap wıth Connectıve Tissue Graft: An Exploratıve Study
Background: The aim of present clinical study was to evaluate the predictive values of baseline inter-dental papilla height (IPH), avascular exposed root surface area (AERSA) and inter-dental clinical attachment loss (CAL) measurements on complete root coverage (CRC) of single gingival recession (GR) defects treated with coronally advanced flap and connective tissue graft technique (CAF+CTG).
Material and Methods: The study group included 65 females and 57 males, aged between 20 and 42 years. A total of 122 recession defects without CAL and with an amount of CAL equal or smaller to the buccal CAL , located at upper and lower incisors and canines were treated with CAF+CTG. IPH, AERSA and CAL parameters were analyzed for possible correlation with CRC after 6 months.
Read the detailed description
The coronally advanced flap (CAF) with connective tissue graft (CTG) has been confirmed as the gold standard for treatment of gingival recessions ). CTG-based procedures provide the best outcomes with superior percentages of mean root coverage (MRC) and complete root coverage (CRC) and keratinized tissue (KT) gain. Data in previous reports show CRC range from 18% to 83% after CAF+CTG in Miller Classes I and II defects which are associated with no inter-dental clinical attachment loss (interdental-CAL) (Recession Type 1-RT1)
The use of CTG under CAF significantly enhances the probability to achieve CRC (%57) in recessions in which interdental-CAL is equal or smaller than the buccal attachment loss (Recession Type 2-RT2). It has been emphasized that CRC percentage was very similar to the result (60%) of a multicentre study on the treatment of RT1 recessions (Cortellini et al. 2009). Moreover, CRC was higher than most of the reports on treatment of RT1 or Miller I and II defects (more than 80%) when baseline interdental-CAL was between 1 and 3 mm Therefore, various CRC outcomes of the literature indicate that there is need for additional defect defining criteria for predicting the outcomes of root coverage (RC) in RT 1 and RT2 (interdental-CAL≤ 3mm) recession defects.
Predetermination of final RC which is important for distinguishing 'expected versus actual' amount of RC was found to be related to inter-dental papilla height (IPH) and inter-dental clinical attachment level (ICAL) by the clinical studies which reported correlation between these two anatomical characteristics and CRC. Recently a new predictive classification of gingival recessions using the baseline avascular exposed root surface area (AERSA) as an identification criterion has been proposed. AERSA resulted as a strong predictor of final RC after laterally positioned flap (LPF) leading to a prognostic model with AERSA explaining 86% of the mean root coverage. In addition, due to anatomic variations, some Miller Class I defects may have larger AERSA than Miller Class II and III defects or there may be smaller Miller Class III defects than Miller Class I and II defects which may significantly influence the treatment results. These results could help to explain the outcome variations among previous studies.
The prognostic anticipation of a certain amount of RC is a complex process including patient-related, tooth/site-related (GRD, root abrasion, ICAL, tooth type, the dimension of inter-dental papilla, AERSA) and technique-related (e.g. quality of the CTG) factors and operator's skill. It is essential to define the most potent prognostic factors' combination which can increase the success and predictability rates, to make CAF+CTG the most convenient RC technique for patients and clinicians. Therefore the aim of this study was to explore the predictive values of baseline IPH, AERSA and ICAL measurements on the final RC outcomes after CAF+CTG in RT1 and RT2 class GR defects.
- Conditions
- Gingival Recessions
- Being tested
- Coronally advanced flap with connective tissue graft
- Keywords
- prognostic factors
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronally advanced flap with connective tissue graftOther
Also called CAF+CTG
Two oblique, divergent releasing incisions extending beyond the mucogingival junction were performed. An intra-sulcular incision was performed at the buccal aspect of the involved tooth. Subsequently, a partial-thickness flap was raised beyond the MGJ. The papilla adjacent to the involved tooth were then de-epithelialized.
The CTG was harvested using a single incision approach from the palate. The graft was positioned on the instrumented root surface immediately apical of the CEJ and then stabilized using a sling compressive crossing suture. The flap was coronally displaced 1-2 mm above the CEJ. A sling suture was placed to stabilize the flap in a coronal position, followed by interrupted sutures on the releasing incisions with an apico-coronal direction.
| Study group | Role | What they receive |
|---|---|---|
| gingival recession type 1 | Other | recession defects without CAL intervention:Coronally advanced flap with connective tissue graft Receives: Other: Coronally advanced flap with connective tissue graft |
| gingival recession type 2 | Other | gingival recession with an amount of CAL equal or smaller to the buccal CAL. Intervention: Coronally advanced flap with connective tissue graft Receives: Other: Coronally advanced flap with connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
values of baseline interdental papill height
in mm
Measured: 1 year
Secondary outcomes (2)
avascular exposed root surface area
.n mm2
Measured: 1 year
interdental clinical attachment level
in mm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionsStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Ozcelik, Cukurova University
- Investigators
- Onur Ozcelik, Prof. Dr, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479633
- Sponsor's protocol ID
- CukurovaU5
- Status last verified
- Jun 2015
- First submitted
- 17 Jun 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predetermınatıon of Root Coverage for Recessıons Treated wıth Coronally Advanced Flap wıth Connectıve Tissue Graft: An Exploratıve Study
- ClinicalTrials.gov ID
- NCT02479633
- Acronym / sponsor ID
- CukurovaU5
- Conditions
- Gingival Recessions
- Keywords
- prognostic factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Jun 2015 (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.
Background: The aim of present clinical study was to evaluate the predictive values of baseline inter-dental papilla height (IPH), avascular exposed root surface area (AERSA) and inter-dental clinical attachment loss (CAL) measurements on complete root coverage (CRC) of single gingival recession (GR) defects treated with coronally advanced flap and connective tissue graft technique (CAF+CTG).
Material and Methods: The study group included 65 females and 57 males, aged between 20 and 42 years. A total of 122 recession defects without CAL and with an amount of CAL equal or smaller to the buccal CAL , located at upper and lower incisors and canines were treated with CAF+CTG. IPH, AERSA and CAL parameters were analyzed for possible correlation with CRC after 6 months.
Detailed description
The coronally advanced flap (CAF) with connective tissue graft (CTG) has been confirmed as the gold standard for treatment of gingival recessions ). CTG-based procedures provide the best outcomes with superior percentages of mean root coverage (MRC) and complete root coverage (CRC) and keratinized tissue (KT) gain. Data in previous reports show CRC range from 18% to 83% after CAF+CTG in Miller Classes I and II defects which are associated with no inter-dental clinical attachment loss (interdental-CAL) (Recession Type 1-RT1)
The use of CTG under CAF significantly enhances the probability to achieve CRC (%57) in recessions in which interdental-CAL is equal or smaller than the buccal attachment loss (Recession Type 2-RT2). It has been emphasized that CRC percentage was very similar to the result (60%) of a multicentre study on the treatment of RT1 recessions (Cortellini et al. 2009). Moreover, CRC was higher than most of the reports on treatment of RT1 or Miller I and II defects (more than 80%) when baseline interdental-CAL was between 1 and 3 mm Therefore, various CRC outcomes of the literature indicate that there is need for additional defect defining criteria for predicting the outcomes of root coverage (RC) in RT 1 and RT2 (interdental-CAL≤ 3mm) recession defects.
Predetermination of final RC which is important for distinguishing 'expected versus actual' amount of RC was found to be related to inter-dental papilla height (IPH) and inter-dental clinical attachment level (ICAL) by the clinical studies which reported correlation between these two anatomical characteristics and CRC. Recently a new predictive classification of gingival recessions using the baseline avascular exposed root surface area (AERSA) as an identification criterion has been proposed. AERSA resulted as a strong predictor of final RC after laterally positioned flap (LPF) leading to a prognostic model with AERSA explaining 86% of the mean root coverage. In addition, due to anatomic variations, some Miller Class I defects may have larger AERSA than Miller Class II and III defects or there may be smaller Miller Class III defects than Miller Class I and II defects which may significantly influence the treatment results. These results could help to explain the outcome variations among previous studies.
The prognostic anticipation of a certain amount of RC is a complex process including patient-related, tooth/site-related (GRD, root abrasion, ICAL, tooth type, the dimension of inter-dental papilla, AERSA) and technique-related (e.g. quality of the CTG) factors and operator's skill. It is essential to define the most potent prognostic factors' combination which can increase the success and predictability rates, to make CAF+CTG the most convenient RC technique for patients and clinicians. Therefore the aim of this study was to explore the predictive values of baseline IPH, AERSA and ICAL measurements on the final RC outcomes after CAF+CTG in RT1 and RT2 class GR defects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gingival recession type 1 | Other | Other: Coronally advanced flap with connective tissue graftrecession defects without CAL intervention:Coronally advanced flap with connective tissue graft |
| gingival recession type 2 | Other | Other: Coronally advanced flap with connective tissue graftgingival recession with an amount of CAL equal or smaller to the buccal CAL. Intervention: Coronally advanced flap with connective tissue graft |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Presence of isolated RT1 and RT2 class gingival recessions with an AERSA ˃9mm2 on upper and lower incisors,
- Presence of identifiable cemento-enamel junction (CEJ); presence of a step ≤1mm at the 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%,
- No occlusal interferences;
Key exclusion criteria (4 listed)
- Patients with a history of periodontitis or abscess formation,
- Mucogingival or periodontal surgery at the experimental site in the last 1 year,
- Presence of systemic disease or taking medication known to interfere with periodontal tissue health,
- Smokers, pregnant patients.
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 |
|---|---|---|
| Coronally advanced flap with connective tissue graftAlso: CAF+CTGTwo oblique, divergent releasing incisions extending beyond the mucogingival junction were performed. An intra-sulcular incision was performed at the buccal aspect of the involved tooth. Subsequently, a partial-thickness flap was raised beyond the MGJ. The papilla adjacent to the involved tooth were then de-epithelialized. The CTG was harvested using a single incision approach from the palate. The graft was positioned on the instrumented root surface immediately apical of the CEJ and then stabilized using a sling compressive crossing suture. The flap was coronally displaced 1-2 mm above the CEJ. A sling suture was placed to stabilize the flap in a coronal position, followed by interrupted sutures on the releasing incisions with an apico-coronal direction. | Other | gingival recession type 1, gingival recession type 2 |
Primary outcome
values of baseline interdental papill height
Time frame: 1 year
in mm
2 secondary outcomes
avascular exposed root surface area
Time frame: 1 year
interdental clinical attachment level
Time frame: 1 year
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 24 Jun 2015.
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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.
Onur Ozcelik, Prof. Dr principal investigator
Professor
Questions about this trial
What is this clinical trial studying?
A study testing Coronally advanced flap with connective tissue graft in people with Gingival Recessions, run by Cukurova University.
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 4 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 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
values of baseline interdental papill height (time frame: 1 year). 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 24 Jun 2015.