Gingival RecessionPhase 4NCT02433899
Microsurgical Versus Conventional Semilunar Coronally Advanced Flap
A Phase 4 study testing MICROSURGERY, MACROSURGERY and Dexamethasone in people with Gingival Recession, run by Universidade Federal Fluminense.
Trial summary
BACKGROUND: The semilunar coronally repositioned flap (SLCRF) has been used for the treatment of recession defects (GR). Recently a microsusgical (MICRO) has been successfully employed with the procedure apparently resulting in improved results, however, no previous controlled clinical study has evaluated the MICRO… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- MICROSURGERY, MACROSURGERY and Dexamethasone
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Apr 2012
- Phase
- Phase 4
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of bilateral Miller class I gingival recessions (≤ 3mm) exhibiting at least 2mm of keratinized tissue width (WKT) in endodontically-vital maxillary canines or premolars.
- These teeth presented shallow (<3mm) probing depth (PD) without bleeding on probing. Moreover, the elegible individuals demonstrated absence of contraindications for periodontal surgery, and were not being taking medications known to interfere with periodontal tissue health or healing in the preceding 6 months.
- Experimental teeth were free of caries or restorations in the areas to be treated.
Who cannot join
- Patients with untreated periodontal disease, smokers, subjects with immunosuppressive systemic diseases (i.e., cancer, AIDS, diabetes) were not included in the study.
- Miller class II, III or class IV recession defects, presence of apical radiolucency or caries or restorations in the areas to be treated, and previous lack of cooperation with the maintenance program (as evaluated by unjustified absence from scheduled maintenance visits, continued traumatic tooth brushing technique or faulty plaque control measures).
About this study
Official title: A Clinical Comparison of Microsurgical Versus Conventional Surgical Approaches for the Semilunar Coronally Advanced Flap
BACKGROUND: The semilunar coronally repositioned flap (SLCRF) has been used for the treatment of recession defects (GR). Recently a microsusgical (MICRO) has been successfully employed with the procedure apparently resulting in improved results, however, no previous controlled clinical study has evaluated the MICRO SLCRF in comparison with SLCRF performed as originally described (MACRO). The objective of the present study was to compare the clinical outcomes of the MICRO and MACRO SLCRF in the treatment of human GR.
METHODS: Fourteen patients, with bilateral Miller class I GR defects were randomly assigned to MICRO or MACRO SLCRF. Clinical parameters, assessed at baseline and 6 months later, included recession height (RECH), recession width (RECW), width of keratinized tissue (WKT), probing depth (PD), clinical attachment level (CAL), pain measurements and esthetic evaluation with the Root Coverage Score (RCS). Inter-measurements differences were analyzed with a Chi-square or a paired t-test, with significance set at α<0.05.
Read the detailed description
Study Population and Experimental Design The study was designed as a randomized, prospective, split-mouth, controlled clinical trial. It was conducted in accordance with the guidelines of the Helsinki Declaration of 1975, as revised in 2000, and after approved by institutional review board approval (CEP CMM/HUAP no 162/2010). Written informed consent was obtained from all patients after thorough explanation of the nature, risks, and benefits of the clinical investigation and associated procedures.
The study population consisted of patients referred for periodontal treatment at the School of Dentistry, Veiga de Almeida University, Brazil. In order to be elegible for the present study, adult individuals met the following inclusion criteria:
- presence of bilateral Miller class I gingival recessions (≤ 3mm)
- at least 2mm of keratinized tissue width (WKT)
- endodontically-vital
- maxillary canines or premolars.
- shallow (<3mm) probing depth (PD)
- no bleeding on probing.
- absence of contraindications for periodontal surgery
- no medications known to interfere with periodontal tissue health or healing
- teeth to be treated free of caries or restorations
Exclusion criteria were:
- presence of untreated periodontal disease
- smokers
- subjects with immunosuppressive systemic diseases (i.e., cancer, AIDS, diabetes)
- Miller class II, III or class IV recession defects,
- presence of apical radiolucency or caries or restorations in the areas to be treated,
- previous lack of cooperation with the maintenance program
Fourteen patients (8 females and 6 males), 25 to 41 years of age (mean age, 31.6 years), were included in the study from January 2010 to December 2010. The primary outcome variable of the study was the reduction of recession depth. Sample size was determined by Power analysis, assuming α of .05, and a standard deviation of 0.7. This calculation indicated that with a sample of 14 subjects, the study would have >95% power to detect a 1-mm difference in recession depth between the two groups.
All patients were subjected to initial periodontal therapy 28 days before the beginning of the study. Treatment included oral hygiene instructions, scaling and root planning where needed, tooth polishing, plaque control measures and correction of traumatic tooth brushing technique. All patients were instructed and trained to use a soft toothbrush and to eliminate habits related to the etiology of the recession. Baseline full mouth plaque and bleeding scores were low. Each defect was randomly assigned to one of the two treatment modalities employed: (a) Controls (n=14): semilunar coronally repositioned flap performed without the aid of visual magnification (MACRO); (b) Test (n=14): SLCRF performed under magnification with a surgical microscope (MACRO) by the toss of a coin immediately before the surgical procedures, which were performed at the same clinical appointment. Single recession defects in 6 canines, 14 first-premolars, and 8 second-premolars were treated. Patients were not informed the site allocation for the surgical procedures.
Clinical data collection Clinical parameters were assessed and all measurements were recorded by a blinded, trained and calibrated examiner (ATD), unaware of the treatment provided, at baseline and 6 months later. Visual plaque score (VPS) and bleeding on probing (BOP) were assessed dichotomously at the mid-buccal location. Recession height (RECH) was measured as the distance from the CEJ to GM. Recession width (RECW) was measured as distance between the lateral borders of the recession at the level of the CEJ. The width of keratinized tissue (WKT) was measured as the distance between the GM and the MGJ. Thickness of the gingival tissues (GT) was measured 2mm apically to GM. PD was measured as the distance from the GM to the bottom of the gingival sulcus. PD and RECH were used to calculate the clinical attachment level (CAL). Measurements for PD and CAL were performed using an UNC #15 periodontal probe. Measurements of RECH, RECW, WKT and GT were performed with an endodontic spreader and rubber stopper (Maillefer, Dentsply, Brasil), and data was acquired with a digital gauge with 0.01mm resolution (Mitutoyo South America, Susano, Brazil).
Aesthetic and patient-related evaluations
Esthetic outcomes were evaluated with the Root Coverage Score (RCS) (Cairo et al 2009) six months after the surgical procedures. Root coverage (RC) is scored zero with no root coverage was obtained (RECH at 6 months is equal to RECH obtained at baseline), three for partial (RECH>0) and six for complete root coverage (RECH=0). Other variables (gingival contour, tissue texture, mucogingival junction alignment and gingival color) are compared to the contra-lateral side and scored up to one point each (zero points if significantly different from contra-lateral side). Thus, this evaluation scale is composed of five independent parameters that result in a total score of 10.
One important patient-related evaluation is the post-surgical pain experienced. In order to quantify the frequence and severity of pain, a visual analog scale (VAS) of pain was employed seven days after the surgical procedure, in which zero meant complete absence of pain and ten the maximum tolerable pain by the patient. Prevalence of pain was documented dichotomously as no pain for VAS scores equal to zero and pain for VAS scores bigger that zero. Severity of pain was quantified by the direct value obtained by the VAS score.
Surgical Procedures were performed by one operator (SK) not involved in clinical data measurements, and patient allocation. Before surgery, each patient was given a single dose of 8mg dexamethasone (EMS, São Paulo, Brasil) to reduce post-surgical edema. Intraoral antisepsis was performed with a 0.12% chlorhexidine rinse (Lacer, Barcelona, Spain). Anesthesia was obtained by regional blocks with 2.0% Mepivacaine with 1:1 00.000 epinephrine (DFL, Rio de Janeiro, Brasil).
Semilunar coronally positioned flap - Conventional approach
The MACRO SLCRF procedure was performed as originally described by Tarnow et al (1986). Briefly, a semilunar incision (SLI) was carried out following the outline of the gingival margin with a 15c surgical blade. This incision ended into the papilla on each interproximal area of the tooth to be treated, but not all the way to the tip of the papilla. At least 2mm of gingiva was preserved on each side of the flap in order to preserve the blood supply. The SLI was curved apically to an extent to guarantee that the apical part of the flap rests on bone after the coronal advancement to cover the root. In order to do that transgingival probing was performed before the incision to determine the position of the bone crest. An intrasulcular incision (ISI) was performed mid-facially. Then, a split-thickness (ST) dissection was performed from the initial incision coronally until connecting to the ISI. The mid-facial tissue was completely released, positioned coronally to the CEJ and held in place against the tooth with a moist gauze pad placed with light pressure, perpendicular to the flap, for five minutes. No sutures were placed, however, a cyanoacrilate adhesive (CAA) was applied over the post-surgical gingival margin and tooth enamel to stabilize the flap.
Semilunar coronally positioned flap - Microsurgical approach
The MICRO SLCRF procedure was performed as described by Bittencourt et al (2006, 2009). Briefly, employing a surgical microscope (DF Vanconcelos, model MC M1232), a SLI was carried out following the outline of the gingival margin with a # 6961 microsurgical blade (Surgistar, California, EUA) under (8x) magnification, the ST dissection, flap advancement and stabilization were performed as descrided above.
Statistical Analysis
All descriptive statistics were expressed as mean +/- standard deviation (SD). Baseline measurements were subjected to inter-group comparisons, and were analyzed by the non-parametric Wilcoxon test or the Chi-square test. Inter-group and intra-group comparisons between baseline and six-month measurements were analyzed by the Wilcoxon test or the Chi-square test. Wilcoxon's signed ranks test was used for intra-group comparisons and the Wilcoxon's rank sums test was used for inter-group comparisons. Statistical significance was set at the 95% probability level (P<0.05).
- Conditions
- Gingival Recession
- Being tested
- MICROSURGERY, MACROSURGERY, Dexamethasone, Chlorhexidine gluconate, 2.0% Mepivacaine + 1:100.000 epinephrine
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICROSURGERYProcedure or surgery
Also called Microsurgical semilunar flap
Semilunar coronally repositioned flap performed under magnification with a surgical microscope
MACROSURGERYProcedure or surgery
Also called Original semilunar flap
Semilunar coronally repositioned flap performed without magnification
DexamethasoneDrug
8mg Dexamethasone, single dose, 1 hour before surgery
Chlorhexidine gluconateDrug
Also called Gengilacer, LACER
Oral rinses with chlorhexidine gluconate, BID, for 14 days
2.0% Mepivacaine + 1:100.000 epinephrineDrug
Also called Mepiadre
Regional block
| Study group | Role | What they receive |
|---|---|---|
| Test - Microsurgical semilunar flap | Experimental | Semilunar coronally repositioned flap performed under magnification with a surgical microscope.
SLI was carried out following the outline of the gingival margin with a microsurgical blade under (8x) magnification. An ISI was performed mid-facially. Then, a split-thickness dissection was performed from the initial incision coronally until connecting to the ISI. The mid-facial tissue was completely released, positioned coronally to the CEJ and held in place against the tooth. A cyanoacrilate adhesive (CAA) was applied over the post-surgical gingival margin and tooth enamel to stabilize the flap. Receives: Procedure: MICROSURGERY; Drug: Dexamethasone; Drug: Chlorhexidine gluconate; Drug: 2.0% Mepivacaine + 1:100.000 epinephrine |
| Control - Conventional Semilunar flap | Active comparator | Semilunar coronally repositioned flap performed without magnification. A semilunar incision (SLI) was carried out with a 15c surgical blade. An ISI was performed mid-facially. Then, a split-thickness dissection was performed from the initial incision coronally until connecting to the ISI. The mid-facial tissue was completely released, positioned coronally to the CEJ and held in place against the tooth. A cyanoacrilate adhesive (CAA) was applied over the post-surgical gingival margin and tooth enamel to stabilize the flap. Receives: Procedure: MACROSURGERY; Drug: Dexamethasone; Drug: Chlorhexidine gluconate; Drug: 2.0% Mepivacaine + 1:100.000 epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root coverage
Distance between the cementum-enamel junction and the gingival margin. Measurements will be performed at baseline (RECH1) and after 6 months (RECH2). The amount of root coverage will be calculated as REC2x100/REC1
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 posted5 May 2015 (estimated)
- Study startOct 2010
- Primary completionApr 2012
- Study completionApr 2012
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronaldo B Santana, DDS,MScD,DSc, Principal investigator, Federal Fluminense University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433899
- Sponsor's protocol ID
- CEP CMM/HUAP no 162/2010
- Status last verified
- Apr 2015
- First submitted
- 8 Jan 2015
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of Microsurgical Versus Conventional Surgical Approaches for the Semilunar Coronally Advanced Flap
- ClinicalTrials.gov ID
- NCT02433899
- Acronym / sponsor ID
- CEP CMM/HUAP no 162/2010
- Conditions
- Gingival Recession
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 5 May 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 semilunar coronally repositioned flap (SLCRF) has been used for the treatment of recession defects (GR). Recently a microsusgical (MICRO) has been successfully employed with the procedure apparently resulting in improved results, however, no previous controlled clinical study has evaluated the MICRO SLCRF in comparison with SLCRF performed as originally described (MACRO). The objective of the present study was to compare the clinical outcomes of the MICRO and MACRO SLCRF in the treatment of human GR.
METHODS: Fourteen patients, with bilateral Miller class I GR defects were randomly assigned to MICRO or MACRO SLCRF. Clinical parameters, assessed at baseline and 6 months later, included recession height (RECH), recession width (RECW), width of keratinized tissue (WKT), probing depth (PD), clinical attachment level (CAL), pain measurements and esthetic evaluation with the Root Coverage Score (RCS). Inter-measurements differences were analyzed with a Chi-square or a paired t-test, with significance set at α<0.05.
Detailed description
Study Population and Experimental Design The study was designed as a randomized, prospective, split-mouth, controlled clinical trial. It was conducted in accordance with the guidelines of the Helsinki Declaration of 1975, as revised in 2000, and after approved by institutional review board approval (CEP CMM/HUAP no 162/2010). Written informed consent was obtained from all patients after thorough explanation of the nature, risks, and benefits of the clinical investigation and associated procedures.
The study population consisted of patients referred for periodontal treatment at the School of Dentistry, Veiga de Almeida University, Brazil. In order to be elegible for the present study, adult individuals met the following inclusion criteria:
- presence of bilateral Miller class I gingival recessions (≤ 3mm)
- at least 2mm of keratinized tissue width (WKT)
- endodontically-vital
- maxillary canines or premolars.
- shallow (<3mm) probing depth (PD)
- no bleeding on probing.
- absence of contraindications for periodontal surgery
- no medications known to interfere with periodontal tissue health or healing
- teeth to be treated free of caries or restorations
Exclusion criteria were:
- presence of untreated periodontal disease
- smokers
- subjects with immunosuppressive systemic diseases (i.e., cancer, AIDS, diabetes)
- Miller class II, III or class IV recession defects,
- presence of apical radiolucency or caries or restorations in the areas to be treated,
- previous lack of cooperation with the maintenance program
Fourteen patients (8 females and 6 males), 25 to 41 years of age (mean age, 31.6 years), were included in the study from January 2010 to December 2010. The primary outcome variable of the study was the reduction of recession depth. Sample size was determined by Power analysis, assuming α of .05, and a standard deviation of 0.7. This calculation indicated that with a sample of 14 subjects, the study would have >95% power to detect a 1-mm difference in recession depth between the two groups.
All patients were subjected to initial periodontal therapy 28 days before the beginning of the study. Treatment included oral hygiene instructions, scaling and root planning where needed, tooth polishing, plaque control measures and correction of traumatic tooth brushing technique. All patients were instructed and trained to use a soft toothbrush and to eliminate habits related to the etiology of the recession. Baseline full mouth plaque and bleeding scores were low. Each defect was randomly assigned to one of the two treatment modalities employed: (a) Controls (n=14): semilunar coronally repositioned flap performed without the aid of visual magnification (MACRO); (b) Test (n=14): SLCRF performed under magnification with a surgical microscope (MACRO) by the toss of a coin immediately before the surgical procedures, which were performed at the same clinical appointment. Single recession defects in 6 canines, 14 first-premolars, and 8 second-premolars were treated. Patients were not informed the site allocation for the surgical procedures.
Clinical data collection Clinical parameters were assessed and all measurements were recorded by a blinded, trained and calibrated examiner (ATD), unaware of the treatment provided, at baseline and 6 months later. Visual plaque score (VPS) and bleeding on probing (BOP) were assessed dichotomously at the mid-buccal location. Recession height (RECH) was measured as the distance from the CEJ to GM. Recession width (RECW) was measured as distance between the lateral borders of the recession at the level of the CEJ. The width of keratinized tissue (WKT) was measured as the distance between the GM and the MGJ. Thickness of the gingival tissues (GT) was measured 2mm apically to GM. PD was measured as the distance from the GM to the bottom of the gingival sulcus. PD and RECH were used to calculate the clinical attachment level (CAL). Measurements for PD and CAL were performed using an UNC #15 periodontal probe. Measurements of RECH, RECW, WKT and GT were performed with an endodontic spreader and rubber stopper (Maillefer, Dentsply, Brasil), and data was acquired with a digital gauge with 0.01mm resolution (Mitutoyo South America, Susano, Brazil).
Aesthetic and patient-related evaluations
Esthetic outcomes were evaluated with the Root Coverage Score (RCS) (Cairo et al 2009) six months after the surgical procedures. Root coverage (RC) is scored zero with no root coverage was obtained (RECH at 6 months is equal to RECH obtained at baseline), three for partial (RECH>0) and six for complete root coverage (RECH=0). Other variables (gingival contour, tissue texture, mucogingival junction alignment and gingival color) are compared to the contra-lateral side and scored up to one point each (zero points if significantly different from contra-lateral side). Thus, this evaluation scale is composed of five independent parameters that result in a total score of 10.
One important patient-related evaluation is the post-surgical pain experienced. In order to quantify the frequence and severity of pain, a visual analog scale (VAS) of pain was employed seven days after the surgical procedure, in which zero meant complete absence of pain and ten the maximum tolerable pain by the patient. Prevalence of pain was documented dichotomously as no pain for VAS scores equal to zero and pain for VAS scores bigger that zero. Severity of pain was quantified by the direct value obtained by the VAS score.
Surgical Procedures were performed by one operator (SK) not involved in clinical data measurements, and patient allocation. Before surgery, each patient was given a single dose of 8mg dexamethasone (EMS, São Paulo, Brasil) to reduce post-surgical edema. Intraoral antisepsis was performed with a 0.12% chlorhexidine rinse (Lacer, Barcelona, Spain). Anesthesia was obtained by regional blocks with 2.0% Mepivacaine with 1:1 00.000 epinephrine (DFL, Rio de Janeiro, Brasil).
Semilunar coronally positioned flap - Conventional approach
The MACRO SLCRF procedure was performed as originally described by Tarnow et al (1986). Briefly, a semilunar incision (SLI) was carried out following the outline of the gingival margin with a 15c surgical blade. This incision ended into the papilla on each interproximal area of the tooth to be treated, but not all the way to the tip of the papilla. At least 2mm of gingiva was preserved on each side of the flap in order to preserve the blood supply. The SLI was curved apically to an extent to guarantee that the apical part of the flap rests on bone after the coronal advancement to cover the root. In order to do that transgingival probing was performed before the incision to determine the position of the bone crest. An intrasulcular incision (ISI) was performed mid-facially. Then, a split-thickness (ST) dissection was performed from the initial incision coronally until connecting to the ISI. The mid-facial tissue was completely released, positioned coronally to the CEJ and held in place against the tooth with a moist gauze pad placed with light pressure, perpendicular to the flap, for five minutes. No sutures were placed, however, a cyanoacrilate adhesive (CAA) was applied over the post-surgical gingival margin and tooth enamel to stabilize the flap.
Semilunar coronally positioned flap - Microsurgical approach
The MICRO SLCRF procedure was performed as described by Bittencourt et al (2006, 2009). Briefly, employing a surgical microscope (DF Vanconcelos, model MC M1232), a SLI was carried out following the outline of the gingival margin with a # 6961 microsurgical blade (Surgistar, California, EUA) under (8x) magnification, the ST dissection, flap advancement and stabilization were performed as descrided above.
Statistical Analysis
All descriptive statistics were expressed as mean +/- standard deviation (SD). Baseline measurements were subjected to inter-group comparisons, and were analyzed by the non-parametric Wilcoxon test or the Chi-square test. Inter-group and intra-group comparisons between baseline and six-month measurements were analyzed by the Wilcoxon test or the Chi-square test. Wilcoxon's signed ranks test was used for intra-group comparisons and the Wilcoxon's rank sums test was used for inter-group comparisons. Statistical significance was set at the 95% probability level (P<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test - Microsurgical semilunar flap | Experimental | Procedure: MICROSURGERY, Drug: Dexamethasone, Drug: Chlorhexidine gluconate, Drug: 2.0% Mepivacaine + 1:100.000 epinephrineSemilunar coronally repositioned flap performed under magnification with a surgical microscope. SLI was carried out following the outline of the gingival margin with a microsurgical blade under (8x) magnification. An ISI was performed mid-facially. Then, a split-thickness dissection was performed from the initial incision coronally until connecting to the ISI. The mid-facial tissue was completely released, positioned coronally to the CEJ and held in place against the tooth. A cyanoacrilate adhesive (CAA) was applied over the post-surgical gingival margin and tooth enamel to stabilize the flap. |
| Control - Conventional Semilunar flap | Active comparator | Procedure: MACROSURGERY, Drug: Dexamethasone, Drug: Chlorhexidine gluconate, Drug: 2.0% Mepivacaine + 1:100.000 epinephrineSemilunar coronally repositioned flap performed without magnification. A semilunar incision (SLI) was carried out with a 15c surgical blade. An ISI was performed mid-facially. Then, a split-thickness dissection was performed from the initial incision coronally until connecting to the ISI. The mid-facial tissue was completely released, positioned coronally to the CEJ and held in place against the tooth. A cyanoacrilate adhesive (CAA) was applied over the post-surgical gingival margin and tooth enamel to stabilize the flap. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of bilateral Miller class I gingival recessions (≤ 3mm) exhibiting at least 2mm of keratinized tissue width (WKT) in endodontically-vital maxillary canines or premolars.
- These teeth presented shallow (<3mm) probing depth (PD) without bleeding on probing. Moreover, the elegible individuals demonstrated absence of contraindications for periodontal surgery, and were not being taking medications known to interfere with periodontal tissue health or healing in the preceding 6 months.
- Experimental teeth were free of caries or restorations in the areas to be treated.
Key exclusion criteria (2 listed)
- Patients with untreated periodontal disease, smokers, subjects with immunosuppressive systemic diseases (i.e., cancer, AIDS, diabetes) were not included in the study.
- Miller class II, III or class IV recession defects, presence of apical radiolucency or caries or restorations in the areas to be treated, and previous lack of cooperation with the maintenance program (as evaluated by unjustified absence from scheduled maintenance visits, continued traumatic tooth brushing technique or faulty plaque control measures).
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 |
|---|---|---|
| MICROSURGERYAlso: Microsurgical semilunar flapSemilunar coronally repositioned flap performed under magnification with a surgical microscope | Procedure or surgery | Test - Microsurgical semilunar flap |
| MACROSURGERYAlso: Original semilunar flapSemilunar coronally repositioned flap performed without magnification | Procedure or surgery | Control - Conventional Semilunar flap |
| Dexamethasone8mg Dexamethasone, single dose, 1 hour before surgery | Drug | Control - Conventional Semilunar flap, Test - Microsurgical semilunar flap |
| Chlorhexidine gluconateAlso: Gengilacer, LACEROral rinses with chlorhexidine gluconate, BID, for 14 days | Drug | Control - Conventional Semilunar flap, Test - Microsurgical semilunar flap |
| 2.0% Mepivacaine + 1:100.000 epinephrineAlso: MepiadreRegional block | Drug | Control - Conventional Semilunar flap, Test - Microsurgical semilunar flap |
Primary outcome
Root coverage
Time frame: 6 months
Distance between the cementum-enamel junction and the gingival margin. Measurements will be performed at baseline (RECH1) and after 6 months (RECH2). The amount of root coverage will be calculated as REC2x100/REC1
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 5 May 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.
Ronaldo B Santana, DDS,MScD,DSc principal investigator
Federal Fluminense University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MICROSURGERY, MACROSURGERY and Dexamethasone in people with Gingival Recession, run by Universidade Federal Fluminense.
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 3 inclusion and 2 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 5 May 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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 5 May 2015.