The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of a Novel Volume-stable Collagen Matrix (VCMX) in the Treatment of Single Gingival Recession Associated With Non-carious Cervical Lesion Partially Restored

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05916716
Recruitment Status : Recruiting
First Posted : June 23, 2023
Last Update Posted : June 23, 2023
Sponsor:
Information provided by (Responsible Party):
Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Gingival recessions (GR) are often associated with non-carious cervical lesions (NCCL), resulting, thus, in a combined defect. This mucogingival condition has a different treatment prognosis when compared with a GR without wearing surface associated and frequently requires a surgical-restorative approach to achieve better esthetics and functional results. A limited number of clinical studies assessed different multidisciplinary protocols for the management of single combined defects and there is evidence that the use of dental materials does not harm the periodontal tissues and does not influence the root coverage obtained by means of subepithelial connective tissue graft (CTG). Although the association between coronally advanced flap (CAF) and CTG provides more predictable and stable outcomes in the long term, its use is related to some drawbacks. Different biomaterials have been developed to overcome these limitations as a possible alternative to autogenous graft. However, despite its potential, there is a lack of studies evaluating its use in treating this type of condition. Thus, this study aims to assess from a clinical and esthetics point of view and patient-centered outcomes, the use of a new collagen matrix (Geistlich Fibro-Gide®) associated with CAF for the management of single combined defects. For such purpose, 50 patients with single RT1 gingival recessions associated with NCCL will be enrolled and randomly allocated to one of the following groups: control group (n=25), partial restoration of cervical lesion and coronally advanced flap for root coverage (PR+CAF) and test group (n=25), partial restoration of cervical lesion and coronally advanced flap associated with volume stable collagen matrix (PR+CAF+VCMX). The two groups will be compared regarding the clinical parameters, among which bleeding on probing (BOP), biofilm accumulation (IP), clinical attachment level (CAL), recession reduction (RecRed), and the percentage of combined defect coverage (%CDC). Patient-reported outcomes such as post-surgery pain and discomfort, time to recover, the decrease of dentin hypersensitive, and aesthetics will be gathered. A professional assessment will be carried out regarding the aesthetic parameters. All these evaluations will be performed at the baseline and three and six months postoperatively.

Condition or disease Intervention/treatment Phase
Gingival Recession, Localized Tooth Abrasion Procedure: Restorative procedure Procedure: Coronally Advanced Flap (CAF). Device: Volume-stable collagen matrix (VCMX) Drug: Amoxicillin 500mg Drug: Sodium dipyrone Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of a Novel Volume-stable Collagen Matrix (VCMX) in the Treatment of Single Gingival Recession Associated With Non-carious Cervical Lesion Partially Restored. A Randomized Clinical Trial
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: PR+CAF
Partial restoration will be performed, and its apical margin will be placed 1 mm beyond the estimated position of the cementoenamel junction. Patients enrolled in this group will receive a coronally advanced flap (CAF). Two horizontal incisions will be performed at the papilla base united by an intrasulcular incision around the tooth. In sequence, releasing incisions will be designed and a split-full-split flap will be raised beyond the mucogingival junction. Sling sutures will be placed to stabilize the flap margin 2 mm coronal to CEJ, followed by interrupted sutures to close the releasing incisions.
 Procedure: Restorative procedure
Under local anesthesia, a rubber dam isolation will be placed at the site and a coronal bevel will be performed at the incisal margin of the NCCL allowing a correct tooth emergence profile. In sequence, acid etching with 35% phosphoric acid will be applied to the area and washed for 30 seconds with a water-air jet. The lesion will be dried with sterile cotton pellets to prevent dehydration. Active application of the adhesive will be performed for 20 seconds, followed by light curing for 30 seconds. The apical margin of the restoration will be placed 1 mm beyond the estimated position of the cementoenamel junction(CEJ) in order to rebuild only the anatomical part of the crown destroyed by the NCCL and 1 mm of the root surface to give the appropriate emergence profile. After rubber dam removal, the restoration will be finished with ultrafine-grained burs, and 48 hours after the restoration procedure, polishing will be completed with diamond paste and felt discs.

Procedure: Coronally Advanced Flap (CAF).
Two horizontal incisions will be performed at the papilla base united by an intrasulcular incision around the tooth. In sequence, releasing incisions will be designed and a split-full-split flap will be raised beyond the mucogingival junction. Then, sling sutures will be placed to stabilize the flap margin 2 mm coronal to CEJ, followed by interrupted sutures to close the releasing incisions.

Drug: Sodium dipyrone
All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.
Other Name: Post operative care
Experimental: PR + CAF + VCMX
Partial restoration will be performed, and its apical margin will be placed 1 mm beyond the estimated position of the cementoenamel junction. Patients enrolled in this group will receive a coronally advanced flap (CAF) associated with a volume-stable collagen matrix (VCMX). Two horizontal incisions will be performed at the papilla base united by an intrasulcular incision around the tooth. In sequence, releasing incisions will be designed and a split-full-split flap will be raised beyond the mucogingival junction. In sequence, VCMX will be cut according to the recession defect and moistened with saline solution. The biomaterial will be placed at the cementoenamel junction level and stabilized in the adjacent surgery papillae by interrupted sutures. Then, sling sutures will be placed to stabilize the flap margin 2 mm coronal to CEJ, followed by interrupted sutures to close the releasing incisions.
 Procedure: Restorative procedure
Under local anesthesia, a rubber dam isolation will be placed at the site and a coronal bevel will be performed at the incisal margin of the NCCL allowing a correct tooth emergence profile. In sequence, acid etching with 35% phosphoric acid will be applied to the area and washed for 30 seconds with a water-air jet. The lesion will be dried with sterile cotton pellets to prevent dehydration. Active application of the adhesive will be performed for 20 seconds, followed by light curing for 30 seconds. The apical margin of the restoration will be placed 1 mm beyond the estimated position of the cementoenamel junction(CEJ) in order to rebuild only the anatomical part of the crown destroyed by the NCCL and 1 mm of the root surface to give the appropriate emergence profile. After rubber dam removal, the restoration will be finished with ultrafine-grained burs, and 48 hours after the restoration procedure, polishing will be completed with diamond paste and felt discs.

Procedure: Coronally Advanced Flap (CAF).
Two horizontal incisions will be performed at the papilla base united by an intrasulcular incision around the tooth. In sequence, releasing incisions will be designed and a split-full-split flap will be raised beyond the mucogingival junction. Then, sling sutures will be placed to stabilize the flap margin 2 mm coronal to CEJ, followed by interrupted sutures to close the releasing incisions.

Device: Volume-stable collagen matrix (VCMX)
VCMX will be cut according to the recession defect and moistened with saline solution. The biomaterial will be placed at the cementoenamel junction (CEJ) level and stabilized in the adjacent surgical papillae by interrupted sutures.

Drug: Amoxicillin 500mg
Participants enrolled in the PR +CAF+VCMX will be instructed to take amoxicillin 500mg (8 hours/8 hours, during 7 days) after the surgical procedures.
Other Name: Post operative care

Drug: Sodium dipyrone
All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.
Other Name: Post operative care


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Recession reduction (RecRed) [ Time Frame: 180 days ]
    Difference between the final depth of gingival recession in millimeters and gingival margin initial position in millimeters measured through a periodontal probe.


Secondary Outcome Measures :
  1. Dentine hypersensitivity [ Time Frame: 180 days ]
    Root sensitivity assessemnt with the air blow test and measurement with a visual analog scale (VAS).

  2. Patient-centered esthetic evaluation [ Time Frame: 180 days ]
    Using a visual analog scale (VAS), patients will be able to report their opinion regarding esthetic

  3. Oral Health Impact Profile [ Time Frame: 14 days ]
    Will be evaluated from a questionnaire with 14 questions based on 7 domains: functional limitations, physical pain, psychological discomfort, physical disability, psychological deficiency and social deficiency. The patient should respond to the questions within 14 days after the surgical procedure, performing a postoperative diary. For each question an answer must be given, represented in numbers, being: 0- Never; 1- Almost never; 2-Occasionally; 3-Quite frequent; 4-Very common; 5-I do not know (Tonetti MS et al. 2017)

  4. Patient Discomfort [ Time Frame: 14 days ]
    By a visual analogic scale (VAS) of 100 mm to assess discomfort, patients will report pain diary during the 14 days after surgery. Scale extremes will be "no pain" to "extreme." (Tonetti et al. 2017).

  5. Number of analgesics [ Time Frame: 14 days ]
    Number of analgesics used during 14 days after the procedure will be reported at the same postoperative diary (Tonetti et al. 2017).

  6. Percentage of Complete Combined Defect Coverage (%CDC) [ Time Frame: 180 days ]
    This assement is calculated as follow: (RecRed x 100)/CD

  7. Modification of the Root Coverage Esthetic Score (MRES) [ Time Frame: 180 days ]
    Professional aesthetic score which evaluates six variables. The variables are :(1) the marginal tissue contour (MTC); (2) Soft tissue texture (STT); (3) mucogingival junction alignment (MGJ); (4) Gingival color (GC) and (5) Restoration/cervical lesion color (R/CLC).

  8. Clinical Parameters [ Time Frame: 180 days ]
    Probing Depth (PD); Relative Gingival Recession (RGR); Relative Clinical Attachment level (RCAL); Keratinized tissue width (KTW); Keratinized tissue thickness (KTT).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult > 20 years old;
  • systemically healthy
  • no signs of active periodontal disease;
  • full-mouth plaque and bleeding score ≤20%;
  • Gingival recession type RT1 associated with NCCL B+ on a vital canine or premolar;

Exclusion Criteria:

  • Patients who had had periodontal surgery on the study area;
  • Smokers patients;
  • Pregnant or lactating patients;
  • Ongoing orthodontic treatment;
  • Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05916716


Contacts
Layout table for location contacts
Contact: Mauro P Santamaria, PhD (12) 39479055 ext +55 mauro.santamaria@unesp.br

Locations
Layout table for location information
Brazil
Sao Paulo State University Recruiting
São José Dos Campos, SP, Brazil, 1224500
Contact: Mauro P Santamaria, PhD    39479373 ext +55    mauro.santamaria@unesp.br   
Contact: Manuela Maria V Miguel, MS    (12) 39479055 ext +55    manuela.miguel@unesp.br   
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Mauro Pedrine Santamaria, Associate Professor, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT05916716    
Other Study ID Numbers: UEPJMF 13
First Posted: June 23, 2023    Key Record Dates
Last Update Posted: June 23, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho:
Gingival Recession
Tooth Abrasion
Biomaterials
Additional relevant MeSH terms:
Layout table for MeSH terms
Gingival Recession
Tooth Abrasion
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy
Tooth Wear
Tooth Diseases
Dipyrone
Amoxicillin
 Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antipyretics