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

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho (Other)

Overall Status

Recruiting

CT.gov ID

NCT05916716

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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 Names:

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

Procedure: Coronally Advanced Flap (CAF).

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 Names:

Post operative care

Drug: Sodium dipyrone

All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.

Other Names:

Post operative care

Outcome Measures

Primary Outcome Measures

Recession reduction (RecRed) [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

Dentine hypersensitivity [180 days]
Root sensitivity assessemnt with the air blow test and measurement with a visual analog scale (VAS).
Patient-centered esthetic evaluation [180 days]
Using a visual analog scale (VAS), patients will be able to report their opinion regarding esthetic
Oral Health Impact Profile [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 [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 [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) [180 days]
This assement is calculated as follow: (RecRed x 100)/CD
Modification of the Root Coverage Esthetic Score (MRES) [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 [180 days]
Probing Depth (PD); Relative Gingival Recession (RGR); Relative Clinical Attachment level (RCAL); Keratinized tissue width (KTW); Keratinized tissue thickness (KTT).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

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