Gingival RecessionLILTNCT02118155
Low-intensity Laser Therapy in the Treatment of Gingival Recession
A study testing Connective tissue graft in people with Gingival Recession, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
The purpose of this study was to evaluate the 6-month outcomes of applying low-intensity laser therapy associated with connective tissue grafts to treat gingival recession. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Jan 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- presenting Miller class I or II gingival recession in the maxillary canines or premolars;
- visible cemento-enamel junction (CEJ) in the teeth included in the study and pulp vitality;
- patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤ 20%;
- patients older than 18 years old;
- probing depth ˂ 3 mm in the included teeth; 6) patients who agreed to participate and signed an informed consent form
Who cannot join
- patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure
- patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure
- smokers or pregnant women
- patients who underwent periodontal surgery in the area of interest; and 5) patients with orthodontic therapy in progress.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
UNESP - ICT Odontologia São José dos Campos
São José dos Campos, São Paulo, 12243-300
About this study
Official title: Connective Tissue Graft Associated or Not With Low Intensity Laser Therapy: A Randomized Clinical Trial
The purpose of this study was to evaluate the 6-month outcomes of applying low-intensity laser therapy associated with connective tissue grafts to treat gingival recession.
Read the detailed description
This was a prospective, parallel and controlled clinical trial. The population evaluated in this study was selected at ICT - São José dos Campos, College of Dentistry.
The selected patients were randomly allocated (by a computer generated list) into:
Group CTG (n = 20) - patients who received connective tissue graft to treat gingival recession Group CTG+LILT (n = 20) - patients who received connective tissue graft associated with 8 applications of low-intensity laser therapy to treat gingival recession.
The surgeries, as well as all postoperative follow-up, were performed at the dental clinic of ICT- UNESP. Surgical areas were anesthetized (2% mepivacaine with 1:100,000 epinephrine). Two horizontal incisions were made at right angles to the adjacent interdental papillae, at the level of the CEJ, without interfering with the gingival margins of neighboring teeth. Two oblique vertical incisions were extended beyond the mucogingival junction, and a trapezoidal mucoperiosteal flap was raised up to the mucogingival junction. After this point, a split-thickness flap was extended apically, releasing the tension and favoring coronal positioning of the flap. The exposed root surface was gently scaled and planed to remove any possible irregularities. Afterward, a thin and small connective tissue graft was harvested from the palate using a scalpel with parallel blades (1.0 mm away from each other). The graft was sutured# using single sutures in the papillae, over the root surface, in such a way that covered the CEJ and the recession. Then, the flap was coronally positioned and sutured to completely cover the graft The patients allocated for the test group received the following protocol for laser application: Five (5) points of irradiation were performed, as depicted in Figure 1. The irradiation was performed with a GaAlAs** diode laser that continuously emitted a wavelength of 660 nm. 30 mW was used for 20 seconds, and the total applied energy density (fluence) was 15 J/cm2 (3 J/cm2 per point and an application time of 4 seconds per point)
Clinical parameters were assessed at baseline and 3 and 6 months post-operatively.
Statistical Analysis The null hypothesis considered in the study was the absence of difference in the clinical parameters between the different groups. For data analysis, the statistical program was used (Sigmaplot). The demographic and clinical data were compared between the groups using Student's t-test. The data were first analyzed for homogeneity using the Shapiro-Wilk test, which indicated non-normal distribution. . Those presenting Shapiro-Wilk p values < 0.05 were analyzed using a Friedman test (for intragroup comparisons) and Mann-Whitney tests (for intergroup comparisons). Patients' esthetics and discomfort measures using VAS were analyzed by T-tests. The frequency of sites that were scored as very good or excellent in each group by QCE analysis, the frequency of complete root coverage, BOP, and the presence or absence of plaque at the site were compared using χ2 tests. Intergroup RES comparisons were performed with a T-test. A significance level of 0.05 was adopted.
- Conditions
- Gingival Recession
- Being tested
- Connective tissue graft
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue graftProcedure or surgery
Periodontal surgical technique to treat gingival recessions
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue graft (CTG) | Sham comparator | The gingival recession defects were treated by connective tissue graft surgical procedure and received the sham application os low-intensity laser therapy. Receives: Procedure: Connective tissue graft |
| Connective tissue graft plus laser (CTG+L) | Experimental | The gingival recession defects were treated by connective tissue graft associated with the application of a LILT protocol Receives: Procedure: Connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of root coverage
Measured: 6 months
Secondary outcomes (1)
Esthetic
Two esthetic evaluations were performed: 1 professional and 1 patient-centered. The professional esthetic evaluation was made using the photographs of the baseline and 6 months after surgery set in a before-and-after panel. The professional evaluation was conducted using the root coverage esthetic score (RES).
Esthetic outcomes were also evaluated from the patient's point of view. Using a hand mirror, the patients viewed the gingival recession before and after 6 months and were asked to rate the esthetics of the tooth included in the study on a VAS scale.
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 posted21 Apr 2014 (estimated)
- Study startOct 2011
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Pedrine Santamaria, UPECLIN HC FM Botucatu Unesp
- Investigators
- Stephanie B Fernandes-Dias, DDS, Ms, Study chair, UPECLIN HC FM Botucatu UnespMaria Aparecida N Jardini, PhD, Study chair, UPECLIN HC FM Botucatu Unesp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118155
- Sponsor's protocol ID
- 0978412.5.0000.0077
- Acronym
- LILT
- Status last verified
- Apr 2014
- First submitted
- 16 Apr 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ozturan S, Durukan SA, Ozcelik O, Seydaoglu G, Haytac MC. Coronally advanced flap adjunct with low intensity laser therapy: a randomized controlled clinical pilot study. J Clin Periodontol. 2011 Nov;38(11):1055-62. doi: 10.1111/j.1600-051X.2011.01774.x. Epub 2011 Sep 15.
PubMed 22092477Santamaria MP, Fernandes-Dias SB, Araujo CF, Lucas da Silva Neves F, Mathias IF, Rebelato Bechara Andere NM, Neves Jardini MA. 2-Year Assessment of Tissue Biostimulation With Low-Level Laser on the Outcomes of Connective Tissue Graft in the Treatment of Single Gingival Recession: A Randomized Clinical Trial. J Periodontol. 2017 Apr;88(4):320-328. doi: 10.1902/jop.2016.160391. Epub 2016 Nov 11.
PubMed 27834120Fernandes-Dias SB, de Marco AC, Santamaria M Jr, Kerbauy WD, Jardini MA, Santamaria MP. Connective tissue graft associated or not with low laser therapy to treat gingival recession: randomized clinical trial. J Clin Periodontol. 2015 Jan;42(1):54-61. doi: 10.1111/jcpe.12328. Epub 2014 Dec 17.
PubMed 25363203
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connective Tissue Graft Associated or Not With Low Intensity Laser Therapy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02118155
- Acronym / sponsor ID
- LILT / 0978412.5.0000.0077
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 Apr 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 purpose of this study was to evaluate the 6-month outcomes of applying low-intensity laser therapy associated with connective tissue grafts to treat gingival recession.
Detailed description
This was a prospective, parallel and controlled clinical trial. The population evaluated in this study was selected at ICT - São José dos Campos, College of Dentistry.
The selected patients were randomly allocated (by a computer generated list) into:
Group CTG (n = 20) - patients who received connective tissue graft to treat gingival recession Group CTG+LILT (n = 20) - patients who received connective tissue graft associated with 8 applications of low-intensity laser therapy to treat gingival recession.
The surgeries, as well as all postoperative follow-up, were performed at the dental clinic of ICT- UNESP. Surgical areas were anesthetized (2% mepivacaine with 1:100,000 epinephrine). Two horizontal incisions were made at right angles to the adjacent interdental papillae, at the level of the CEJ, without interfering with the gingival margins of neighboring teeth. Two oblique vertical incisions were extended beyond the mucogingival junction, and a trapezoidal mucoperiosteal flap was raised up to the mucogingival junction. After this point, a split-thickness flap was extended apically, releasing the tension and favoring coronal positioning of the flap. The exposed root surface was gently scaled and planed to remove any possible irregularities. Afterward, a thin and small connective tissue graft was harvested from the palate using a scalpel with parallel blades (1.0 mm away from each other). The graft was sutured# using single sutures in the papillae, over the root surface, in such a way that covered the CEJ and the recession. Then, the flap was coronally positioned and sutured to completely cover the graft The patients allocated for the test group received the following protocol for laser application: Five (5) points of irradiation were performed, as depicted in Figure 1. The irradiation was performed with a GaAlAs** diode laser that continuously emitted a wavelength of 660 nm. 30 mW was used for 20 seconds, and the total applied energy density (fluence) was 15 J/cm2 (3 J/cm2 per point and an application time of 4 seconds per point)
Clinical parameters were assessed at baseline and 3 and 6 months post-operatively.
Statistical Analysis The null hypothesis considered in the study was the absence of difference in the clinical parameters between the different groups. For data analysis, the statistical program was used (Sigmaplot). The demographic and clinical data were compared between the groups using Student's t-test. The data were first analyzed for homogeneity using the Shapiro-Wilk test, which indicated non-normal distribution. . Those presenting Shapiro-Wilk p values < 0.05 were analyzed using a Friedman test (for intragroup comparisons) and Mann-Whitney tests (for intergroup comparisons). Patients' esthetics and discomfort measures using VAS were analyzed by T-tests. The frequency of sites that were scored as very good or excellent in each group by QCE analysis, the frequency of complete root coverage, BOP, and the presence or absence of plaque at the site were compared using χ2 tests. Intergroup RES comparisons were performed with a T-test. A significance level of 0.05 was adopted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective tissue graft (CTG) | Sham comparator | Procedure: Connective tissue graftThe gingival recession defects were treated by connective tissue graft surgical procedure and received the sham application os low-intensity laser therapy. |
| Connective tissue graft plus laser (CTG+L) | Experimental | Procedure: Connective tissue graftThe gingival recession defects were treated by connective tissue graft associated with the application of a LILT protocol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- presenting Miller class I or II gingival recession in the maxillary canines or premolars;
- visible cemento-enamel junction (CEJ) in the teeth included in the study and pulp vitality;
- patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤ 20%;
- patients older than 18 years old;
- probing depth ˂ 3 mm in the included teeth; 6) patients who agreed to participate and signed an informed consent form
Key exclusion criteria (4 listed)
- patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure
- patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure
- smokers or pregnant women
- patients who underwent periodontal surgery in the area of interest; and 5) patients with orthodontic therapy in progress.
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 |
|---|---|---|
| Connective tissue graftPeriodontal surgical technique to treat gingival recessions | Procedure or surgery | Connective tissue graft (CTG), Connective tissue graft plus laser (CTG+L) |
Primary outcome
Percentage of root coverage
Time frame: 6 months
1 secondary outcome
Esthetic
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 21 Apr 2014.
- Background: PubMed 22092477Ozturan S, Durukan SA, Ozcelik O, Seydaoglu G, Haytac MC. Coronally advanced flap adjunct with low intensity laser therapy: a randomized controlled clinical pilot study. J Clin Periodontol. 2011 Nov;38(11):1055-62. doi: 10.1111/j.1600-051X.2011.01774.x. Epub 2011 Sep 15.
- Derived from this study: PubMed 27834120Santamaria MP, Fernandes-Dias SB, Araujo CF, Lucas da Silva Neves F, Mathias IF, Rebelato Bechara Andere NM, Neves Jardini MA. 2-Year Assessment of Tissue Biostimulation With Low-Level Laser on the Outcomes of Connective Tissue Graft in the Treatment of Single Gingival Recession: A Randomized Clinical Trial. J Periodontol. 2017 Apr;88(4):320-328. doi: 10.1902/jop.2016.160391. Epub 2016 Nov 11.
- Derived from this study: PubMed 25363203Fernandes-Dias SB, de Marco AC, Santamaria M Jr, Kerbauy WD, Jardini MA, Santamaria MP. Connective tissue graft associated or not with low laser therapy to treat gingival recession: randomized clinical trial. J Clin Periodontol. 2015 Jan;42(1):54-61. doi: 10.1111/jcpe.12328. Epub 2014 Dec 17.
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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.
Stephanie B Fernandes-Dias, DDS, Ms study chair
UPECLIN HC FM Botucatu Unesp
Maria Aparecida N Jardini, PhD study chair
UPECLIN HC FM Botucatu Unesp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue graft in people with Gingival Recession, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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 21 Apr 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Percentage of 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?
On the ClinicalTrials.gov record for NCT02118155, which also lists 3 linked publications.
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 21 Apr 2014.