Use of a Novel Volume-stable Collagen Matrix (VCMX) in the Treatment of Single Gingival Recession Associated With Non-carious Cervical Lesion Partially Restored
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ClinicalTrials.gov Identifier: NCT05916716 |
Recruitment Status :
Recruiting
First Posted : June 23, 2023
Last Update Posted : June 23, 2023
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Condition or disease | Intervention/treatment | Phase |
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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 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 |
Arm | Intervention/treatment |
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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.
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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 |
- 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.
- Dentine hypersensitivity [ Time Frame: 180 days ]Root sensitivity assessemnt with the air blow test and measurement with a visual analog scale (VAS).
- Patient-centered esthetic evaluation [ Time Frame: 180 days ]Using a visual analog scale (VAS), patients will be able to report their opinion regarding esthetic
- 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)
- 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).
- 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).
- Percentage of Complete Combined Defect Coverage (%CDC) [ Time Frame: 180 days ]This assement is calculated as follow: (RecRed x 100)/CD
- 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).
- 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).
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Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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
Contact: Mauro P Santamaria, PhD | (12) 39479055 ext +55 | mauro.santamaria@unesp.br |
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 |
Other Publications:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gingival Recession Tooth Abrasion Biomaterials |
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 |