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Gingival Recession, GeneralizedNCT04093674

Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Two Types of SCTG

A study testing de-epithelized (DE) SCTG in people with Gingival Recession, Generalized, run by University of Sao Paulo.

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

This split-mouth randomized clinical trial compared two different types of subepithelial connective tissue grafts (SCTG) considering clinical parameters and patient-centered outcomes in patients with bilateral RT 1 multiple gingival recessions after 6 months postoperatively. 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, Generalized
What is being tested?
de-epithelized (DE) SCTG
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
No sites listed yet
Study dates
1 Feb 2015to 1 Feb 2019
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

  • systemically healthy patients between 18 and 70 years
  • clinical diagnosis of bilateral multiple gingival recessions, recession type (RT) 1 (Cairo et al. 2011) with at least one gingival recession ≥ 2 mm on each side, including canines and premolars.

Who cannot join

  • abnormal teeth position
  • smokers, pregnant or nursing women
  • parafunctional habits
  • plaque and bleeding indexes (Ainamo \& Bay, 1975) above 20%
  • previous periodontal surgeries on selected sites.

About this study

Official title: Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Double Blade Scalpel (DBS) and De-epithelized (DE) SCTG Associated With Coronally Advanced Flap (CAF): a Split-mouth Randomized Clinical Trial

This split-mouth randomized clinical trial compared two different types of subepithelial connective tissue grafts (SCTG) considering clinical parameters and patient-centered outcomes in patients with bilateral RT 1 multiple gingival recessions after 6 months postoperatively. 21 patients with 84 sites were surgically treated with coronally advanced flap (CAF) associated with SCTG harvested by: double blade scalpel (DBS) and de-epithelized (DE) SCTG. Periodontal clinical parameters and aesthetics were evaluated by a calibrated periodontist at baseline and after 6 months. Patient-centered outcomes related to pain/discomfort and aesthetics were assessed with Visual Analogue Scale (VAS) after 7 days and 6 months, respectively. Gingival blood flows were analyzed by Laser Doppler flowmetry (FLD) at baseline and 2, 7 and 14 days postoperatively.

Read the detailed description

Clinical parameters and patient-centered outcomes

Periodontal clinical examination was performed by a blind and calibrated examiner (intra-class correlation coefficient = 0.72) using a North Carolina periodontal probe (PCPUNC-Hu-Friedy®). Periodontal parameters were evaluated at baseline and after 6 months postoperatively and included:

  1. Recession depth (RD) - Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth;
  2. Recession width (RW) - Distance between interproximal gingival margins of GR with periodontal probe positioned at CEJ;
  3. Probing depth (PD) - Distance in millimeters from the gingival margin to the bottom of the gingival sulcus;
  4. Clinical attachment level (CAL) - Distance in millimeters from the CEJ to the bottom of the gingival sulcus;
  5. Keratinized tissue width (KTW) - Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth;
  6. Keratinized tissue thickness (KTT): determined 1.5 mm apically to gingival margin with an anesthesia needle and a rubber endodontic stop inserted perpendicularly into the soft tissue and measured with a digital caliper.

The index proposed by Zucchelli \& DeSanctis (2000) was used to calculate percentage of root coverage (%RC), as follows:

RRC=(100.(RD baseline-RD 6 months))/(RD baseline) Patient centered outcomes and professional assessment were evaluated with visual analog scales (VAS). VAS was administered verbally to the patients to assess aesthetics and postoperative pain/discomfort. Patients were asked to make a mark in a scale between 0 (not satisfied or extreme pain) and 10 (very satisfied or no pain). Pain and discomfort were recorded after 7 days and patient´s aesthetic evaluation after 6 months. An experienced periodontist (intra-class correlation coefficient = 0.95) evaluated aesthetic outcome after 6 months.

The Laser Doppler flowmetry (LDF) technique (VMS-LDF2 DUAL CHANNEL- Laser Doppler Blood Flow and Temperature Monitor (Moor instruments- process number-FAPESP 2012/13331-2) was used to evaluate blood flow on the recipient sites. LDF is equipped with a laser diode that emits in the infrared spectrum range (Maximum power - 2.5mW, wavelenghts 785nm±10nm). Measurements with LDF were performed with two probes for 1 minute and 30 seconds. These measurements were recorded three times for each site with intervals of one minute.

Being tested
de-epithelized (DE) SCTG
Keywords
connective tissue, randomized controlled trial, gingival recession, patient outcome assessment
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • de-epithelized (DE) SCTGProcedure or surgery

    Also called double blade scalpel (DBS) SCTG

    subepithelial connective tissue grafts

Study groups in NCT04093674
Study groupRoleWhat they receive
Clinical evaluationExperimentalClinical periodontal parameters
Receives: Procedure: de-epithelized (DE) SCTG
Laser Doppler FlowmetryExperimentalLaser Doppler Flowmetry evaluation
Receives: Procedure: de-epithelized (DE) SCTG
Patient centered outcomesExperimentalPain and discomfort/ Esthetics
Receives: Procedure: de-epithelized (DE) SCTG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of root coverage based on Recession depth at baseline and after 6 months

    Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth

    Measured: 6 months

Secondary outcomes (8)

  1. Variation on: Recession width (RW) comparing baseline measurements to 6 months.

    Recession width (RW) - Distance im milimeters between interproximal gingival margins of GR with periodontal probe positioned at CEJ

    Measured: 6 months

  2. Variation on: Probing depth (PD) comparing baseline measurements to 6 months.

    Distance in millimeters from the gingival margin to the bottom of the gingival sulcus;

    Measured: 6 months

  3. Variation on: Clinical attachment level (CAL) comparing baseline measurements to 6 months.

    Distance in millimeters from the CEJ to the bottom of the gingival sulcus;

    Measured: 6 months

  4. Variation on: Keratinized tissue width (KTW) comparing baseline measurements to 6 months.

    Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth;

    Measured: 6 months

  5. Variation on: Keratinized tissue thickness (KTT) comparing baseline measurements to 6 months.

    Determined 1.5 mm apically to gingival margin with an anesthesia needle and a rubber endodontic stop inserted perpendicularly into the soft tissue and measured with a digital caliper (determined in mm).

    Measured: 6 months

  6. Pain and discomfort- Patient centered outcomes

    Pain and discomfort assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (extreme pain) and 10 (no pain)

    Measured: 7 days

  7. Esthetics-Patient centered outcomes

    Esthetics assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (not satisfied) and 10 (very satisfied)

    Measured: 6 months

  8. Esthetics-Periodontist evaluation

    Esthetics assessed using Visual Analog Scale: an experienced periodontist make a mark in a scale between 0 (not satisfied) and 10 (very satisfied)

    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 posted18 Sep 2019
  2. Study start1 Feb 2015
  3. Primary completion1 Feb 2017
  4. Study completion1 Feb 2019

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
Sequential
Model description
Split mouth
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04093674
Sponsor's protocol ID
SCTG21
Status last verified
Sep 2019
First submitted
10 Sep 2019
Last updated
18 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.

    PubMed 24640997

Questions about this trial

What is this clinical trial studying?

A study testing de-epithelized (DE) SCTG in people with Gingival Recession, Generalized, run by University of Sao Paulo.

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 2 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 18 Sep 2019. 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?

Percentage of root coverage based on Recession depth at baseline and after 6 months (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 NCT04093674, which also lists 1 linked publication.

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 18 Sep 2019.

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