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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Brazil

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.

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 groups in NCT02118155
Study groupRoleWhat they receive
Connective tissue graft (CTG)Sham comparatorThe 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)ExperimentalThe 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.

  1. Percentage of root coverage

    Measured: 6 months

Secondary outcomes (1)
  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.

  1. First posted21 Apr 2014 (estimated)
  2. Study startOct 2011
  3. Primary completionDec 2013
  4. Study completionJan 2014

Resources

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)
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 22092477
  • Santamaria 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 27834120
  • Fernandes-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

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.

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