Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Two Types of SCTG
Primary Purpose
Gingival Recession, Generalized
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
de-epithelized (DE) SCTG
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession, Generalized focused on measuring connective tissue, randomized controlled trial, gingival recession, patient outcome assessment
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Clinical evaluation
Laser Doppler Flowmetry
Patient centered outcomes
Arm Description
Clinical periodontal parameters
Laser Doppler Flowmetry evaluation
Pain and discomfort/ Esthetics
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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;
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;
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;
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).
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)
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)
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)
Full Information
NCT ID
NCT04093674
First Posted
September 10, 2019
Last Updated
September 16, 2019
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT04093674
Brief Title
Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Two Types of SCTG
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
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:
Recession depth (RD) - Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth;
Recession width (RW) - Distance between interproximal gingival margins of GR with periodontal probe positioned at CEJ;
Probing depth (PD) - Distance in millimeters from the gingival margin to the bottom of the gingival sulcus;
Clinical attachment level (CAL) - Distance in millimeters from the CEJ to the bottom of the gingival sulcus;
Keratinized tissue width (KTW) - Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Generalized
Keywords
connective tissue, randomized controlled trial, gingival recession, patient outcome assessment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Split mouth
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical evaluation
Arm Type
Experimental
Arm Description
Clinical periodontal parameters
Arm Title
Laser Doppler Flowmetry
Arm Type
Experimental
Arm Description
Laser Doppler Flowmetry evaluation
Arm Title
Patient centered outcomes
Arm Type
Experimental
Arm Description
Pain and discomfort/ Esthetics
Intervention Type
Procedure
Intervention Name(s)
de-epithelized (DE) SCTG
Other Intervention Name(s)
double blade scalpel (DBS) SCTG
Intervention Description
subepithelial connective tissue grafts
Primary Outcome Measure Information:
Title
Percentage of root coverage based on Recession depth at baseline and after 6 months
Description
Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Variation on: Recession width (RW) comparing baseline measurements to 6 months.
Description
Recession width (RW) - Distance im milimeters between interproximal gingival margins of GR with periodontal probe positioned at CEJ
Time Frame
6 months
Title
Variation on: Probing depth (PD) comparing baseline measurements to 6 months.
Description
Distance in millimeters from the gingival margin to the bottom of the gingival sulcus;
Time Frame
6 months
Title
Variation on: Clinical attachment level (CAL) comparing baseline measurements to 6 months.
Description
Distance in millimeters from the CEJ to the bottom of the gingival sulcus;
Time Frame
6 months
Title
Variation on: Keratinized tissue width (KTW) comparing baseline measurements to 6 months.
Description
Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth;
Time Frame
6 months
Title
Variation on: Keratinized tissue thickness (KTT) comparing baseline measurements to 6 months.
Description
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).
Time Frame
6 months
Title
Pain and discomfort- Patient centered outcomes
Description
Pain and discomfort assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (extreme pain) and 10 (no pain)
Time Frame
7 days
Title
Esthetics-Patient centered outcomes
Description
Esthetics assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (not satisfied) and 10 (very satisfied)
Time Frame
6 months
Title
Esthetics-Periodontist evaluation
Description
Esthetics assessed using Visual Analog Scale: an experienced periodontist make a mark in a scale between 0 (not satisfied) and 10 (very satisfied)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Laser doppler flowmetry
Description
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).
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana S Ragghianti Zangrando, Professor
Organizational Affiliation
Bauru School of Dentistry-University of Sao Paulo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24640997
Citation
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.
Results Reference
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Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Two Types of SCTG
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