Gingival DiseasesNCT02229669
Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions
A study testing Horizontal incisions and Oblique incisions in people with Gingival Diseases, run by Paulista University.
Trial summary
This study compared the clinical outcomes of coronally advanced flap using two different surgical strategies in the treatment of multiple gingival recessions. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gingival Diseases
- What is being tested?
- Horizontal incisions and Oblique incisions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jul 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Systemically healthy subjects
- Patients should have bilateral Class I and II MGRs (Miller 1985) in maxillary tooth (at least three recession-type defects affecting adjacent teeth in each side of the maxilla).
- At least 20 teeth and no sites with attachment loss and probing pocket depth (PPD) > 3 mm.
- Full-mouth plaque and bleeding on probing of < 20%.
- Involved tooth should present tooth vitality, absence of caries, restorations or extensive non-carious cervical lesion.
Who cannot join
- History of smoking.
- Antimicrobial and anti-inflammatory therapies in the previous 2 months.
- Previous mucogingival surgery at the region to be treated
- Systemic conditions that could affect tissue healing (e.g. diabetes).
- Use of orthodontic appliances.
About this study
Official title: Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions: A Split-mouth RCT
This study compared the clinical outcomes of coronally advanced flap using two different surgical strategies in the treatment of multiple gingival recessions.
Read the detailed description
The objective of this split-mouth, randomized controlled trial was to compare the clinical outcomes of coronally advanced flap (CAF) using two different surgical strategies in the treatment of multiple gingival recessions. Recessions were randomly treated according to a split-mouth design by means of: CAF with oblique interdental incisions (OBL technique) or CAF with horizontal interdental incisions (HOR technique). Marginal gingival recession (REC), clinical attachment level (CAL), pocket probing depth (PPD), height of keratinized tissue (HKT) and thickness of keratinized tissue (TKT) were measured at baseline, 3 and 6 months after treatment. Patient-centered outcomes concerning morbidity and improvement in the esthetic appearance were recorded using a Visual Analogue Scale (VAS).
- Conditions
- Gingival Diseases
- Being tested
- Horizontal incisions, Oblique incisions
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizontal incisionsProcedure or surgery
Performed by using horizontal interdental incisions. An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions. A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically. A sulcular incision was made to link the second incisions and the blade was inserted (2 to 3 mm) extending beyond the mucogingival junction (MGJ), to create a uniform split-thickness flap. The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure. Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed. Passive closure of the wound margins without tension was achieved with interrupted coaptation.
Oblique incisionsProcedure or surgery
Coronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli \& De Sanctis (2000). Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction. During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions. Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed.
| Study group | Role | What they receive |
|---|---|---|
| Horizontal incisions | Experimental | Coronally advanced flap was performed by using horizontal interdental incisions. An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions. A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically. A sulcular incision was made to link the second incisions and the blade was inserted extending beyond the mucogingival junction, to create a uniform split-thickness flap. The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure. Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed. Receives: Procedure: Horizontal incisions; Procedure: Oblique incisions |
| Oblique incisions | Experimental | Coronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli \& De Sanctis (2000). Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction. During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions. Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed. Receives: Procedure: Horizontal incisions; Procedure: Oblique incisions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Marginal gingival recession to 6 months
Measured: baseline, and at 3 and 6 months post-surgery
Secondary outcomes (4)
height of keratinized tissue
Measured: Baseline, 3 and 6 months
thickness of keratinized tissue
Measured: baseline, 3 and 6 months
Clinical attachment level
Measured: baseline, 3 and 6 months
Probing deph
Measured: baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startMar 2011
- Primary completionAug 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paulista University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Barrella, Paulista University
- Investigators
- Suzana Pimentel, PHD, Principal investigator, Paulista UniversityGuilherme Barrella, MS, Study chair, Paulista University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229669
- Sponsor's protocol ID
- U1111-1158-9611
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2014
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions: A Split-mouth RCT
- ClinicalTrials.gov ID
- NCT02229669
- Acronym / sponsor ID
- U1111-1158-9611
- Conditions
- Gingival Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Paulista UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Sep 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.
This study compared the clinical outcomes of coronally advanced flap using two different surgical strategies in the treatment of multiple gingival recessions.
Detailed description
The objective of this split-mouth, randomized controlled trial was to compare the clinical outcomes of coronally advanced flap (CAF) using two different surgical strategies in the treatment of multiple gingival recessions. Recessions were randomly treated according to a split-mouth design by means of: CAF with oblique interdental incisions (OBL technique) or CAF with horizontal interdental incisions (HOR technique). Marginal gingival recession (REC), clinical attachment level (CAL), pocket probing depth (PPD), height of keratinized tissue (HKT) and thickness of keratinized tissue (TKT) were measured at baseline, 3 and 6 months after treatment. Patient-centered outcomes concerning morbidity and improvement in the esthetic appearance were recorded using a Visual Analogue Scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Horizontal incisions | Experimental | Procedure: Horizontal incisions, Procedure: Oblique incisionsCoronally advanced flap was performed by using horizontal interdental incisions. An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions. A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically. A sulcular incision was made to link the second incisions and the blade was inserted extending beyond the mucogingival junction, to create a uniform split-thickness flap. The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure. Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed. |
| Oblique incisions | Experimental | Procedure: Horizontal incisions, Procedure: Oblique incisionsCoronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli \& De Sanctis (2000). Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction. During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions. Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy subjects
- Patients should have bilateral Class I and II MGRs (Miller 1985) in maxillary tooth (at least three recession-type defects affecting adjacent teeth in each side of the maxilla).
- At least 20 teeth and no sites with attachment loss and probing pocket depth (PPD) > 3 mm.
- Full-mouth plaque and bleeding on probing of < 20%.
- Involved tooth should present tooth vitality, absence of caries, restorations or extensive non-carious cervical lesion.
Key exclusion criteria (5 listed)
- History of smoking.
- Antimicrobial and anti-inflammatory therapies in the previous 2 months.
- Previous mucogingival surgery at the region to be treated
- Systemic conditions that could affect tissue healing (e.g. diabetes).
- Use of orthodontic appliances.
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 |
|---|---|---|
| Horizontal incisionsPerformed by using horizontal interdental incisions. An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions. A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically. A sulcular incision was made to link the second incisions and the blade was inserted (2 to 3 mm) extending beyond the mucogingival junction (MGJ), to create a uniform split-thickness flap. The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure. Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed. Passive closure of the wound margins without tension was achieved with interrupted coaptation. | Procedure or surgery | Horizontal incisions, Oblique incisions |
| Oblique incisionsCoronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli \& De Sanctis (2000). Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction. During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions. Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed. | Procedure or surgery | Horizontal incisions, Oblique incisions |
Primary outcome
Change from baseline in Marginal gingival recession to 6 months
Time frame: baseline, and at 3 and 6 months post-surgery
4 secondary outcomes
height of keratinized tissue
Time frame: Baseline, 3 and 6 months
thickness of keratinized tissue
Time frame: baseline, 3 and 6 months
Clinical attachment level
Time frame: baseline, 3 and 6 months
Probing deph
Time frame: baseline, 3 and 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 1 Sep 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.
Suzana Pimentel, PHD principal investigator
Paulista University
Guilherme Barrella, MS study chair
Paulista University
Questions about this trial
What is this clinical trial studying?
A study testing Horizontal incisions and Oblique incisions in people with Gingival Diseases, run by Paulista 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 5 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 1 Sep 2014. 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?
Change from baseline in Marginal gingival recession to 6 months (time frame: baseline, and at 3 and 6 months post-surgery). 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 1 Sep 2014.