Gingival Recession, LocalizedNCT05916716
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 study testing Restorative procedure, Coronally Advanced Flap (CAF). and Volume-stable collagen matrix (VCMX) in people with Gingival Recession, Localized and Tooth Abrasion, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized, Tooth Abrasion
- What is being tested?
- Restorative procedure, Coronally Advanced Flap (CAF). and Volume-stable collagen matrix (VCMX)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2022to 1 Dec 2023
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Sao Paulo State University
São José dos Campos, São Paulo, 1224500
Mauro P Santamaria, PhD, 39479373 ext. +55, mauro.santamaria@unesp.br
Manuela Maria V Miguel, MS, (12) 39479055 ext. +55, manuela.miguel@unesp.br
About this study
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
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.
- Conditions
- Gingival Recession, Localized, Tooth Abrasion
- Being tested
- Restorative procedure, Coronally Advanced Flap (CAF)., Volume-stable collagen matrix (VCMX), Amoxicillin 500mg, Sodium dipyrone
- Keywords
- Gingival Recession, Tooth Abrasion, Biomaterials
- Medical subject headings
- Gingival Recession, Tooth Abrasion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restorative procedureProcedure or surgery
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.
Coronally Advanced Flap (CAF).Procedure or surgery
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.
Volume-stable collagen matrix (VCMX)Device
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.
Amoxicillin 500mgDrug
Also called Post operative care
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.
Sodium dipyroneDrug
Also called Post operative care
All participants will be instructed to take 500 mg sodium dipyrone just in case of pain.
| Study group | Role | What they receive |
|---|---|---|
| PR+CAF | Active comparator | 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. Receives: Procedure: Restorative procedure; Procedure: Coronally Advanced Flap (CAF).; Drug: Sodium dipyrone |
| PR + CAF + VCMX | Experimental | 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. Receives: Procedure: Restorative procedure; Procedure: Coronally Advanced Flap (CAF).; Device: Volume-stable collagen matrix (VCMX); Drug: Amoxicillin 500mg; Drug: Sodium dipyrone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession reduction (RecRed)
Difference between the final depth of gingival recession in millimeters and gingival margin initial position in millimeters measured through a periodontal probe.
Measured: 180 days
Secondary outcomes (8)
Dentine hypersensitivity
Root sensitivity assessemnt with the air blow test and measurement with a visual analog scale (VAS).
Measured: 180 days
Patient-centered esthetic evaluation
Using a visual analog scale (VAS), patients will be able to report their opinion regarding esthetic
Measured: 180 days
Oral Health Impact Profile
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)
Measured: 14 days
Patient Discomfort
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).
Measured: 14 days
Number of analgesics
Number of analgesics used during 14 days after the procedure will be reported at the same postoperative diary (Tonetti et al. 2017).
Measured: 14 days
Percentage of Complete Combined Defect Coverage (%CDC)
This assement is calculated as follow: (RecRed x 100)/CD
Measured: 180 days
Modification of the Root Coverage Esthetic Score (MRES)
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).
Measured: 180 days
Clinical Parameters
Probing Depth (PD); Relative Gingival Recession (RGR); Relative Clinical Attachment level (RCAL); Keratinized tissue width (KTW); Keratinized tissue thickness (KTT).
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Aug 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, LocalizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916716
- Sponsor's protocol ID
- UEPJMF 13
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Santamaria MP, Miguel MMV, Rossato A, Bonafe ACF, Ferraz LFF, Dos Santos LM, Mathias-Santamaria IF. New Volume-Stable Collagen Matrix and Modified Coronally Advanced Flap to Treat Multiple Gingival Recessions Associated With Partially Restored Non-Carious Cervical Lesions: A Case Report. Clin Adv Periodontics. 2022 Jun;12(2):69-74. doi: 10.1002/cap.10142. Epub 2020 Dec 16.
PubMed 33289326Santamaria MP, Mathias-Santamaria IF, Ferraz LFF, Casarin RCV, Romito GA, Sallum EA, Pini-Prato GP, Casati MZ. Rethinking the decision-making process to treat gingival recession associated with non-carious cervical lesions. Braz Oral Res. 2021 Sep 24;35(Supp 2):e096. doi: 10.1590/1807-3107bor-2021.vol35.0096. eCollection 2021.
PubMed 34586210Santamaria MP, Fernandes-Dias SB, Araujo CF, Lucas da Silva Neves F, Mathias IF, Rebelato Bechara Andere NM, Neves Jardini MA. 2-Year Assessment of Tissue Biostimulation With Low-Level Laser on the Outcomes of Connective Tissue Graft in the Treatment of Single Gingival Recession: A Randomized Clinical Trial. J Periodontol. 2017 Apr;88(4):320-328. doi: 10.1902/jop.2016.160391. Epub 2016 Nov 11.
PubMed 27834120de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
PubMed 17309597Mathias-Santamaria IF, Silveira CA, Rossato A, Sampaio de Melo MA, Bresciani E, Santamaria MP. Single gingival recession associated with non-carious cervical lesion treated by partial restoration and coronally advanced flap with or without xenogenous collagen matrix: A randomized clinical trial evaluating the coverage procedures and restorative protocol. J Periodontol. 2022 Apr;93(4):504-514. doi: 10.1002/JPER.21-0358. Epub 2021 Aug 21.
PubMed 34310715Stefanini M, Mounssif I, Barootchi S, Tavelli L, Wang HL, Zucchelli G. An exploratory clinical study evaluating safety and performance of a volume-stable collagen matrix with coronally advanced flap for single gingival recession treatment. Clin Oral Investig. 2020 Sep;24(9):3181-3191. doi: 10.1007/s00784-019-03192-5. Epub 2020 May 2.
PubMed 32361892Santamaria MP, Miguel MMV, Rossato A, Bonafe ACF, de Souza IV, Martins TM, Nunes MP, Mathias-Santamaria IF. Volume-stable collagen matrix to treat gingival recession associated with non-carious cervical lesions: Randomized clinical trial. J Periodontol. 2026 Jan;97(1):62-73. doi: 10.1002/jper.11386. Epub 2025 Aug 21.
PubMed 40838330
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05916716
- Acronym / sponsor ID
- UEPJMF 13
- Conditions
- Gingival Recession, Localized, Tooth Abrasion
- Keywords
- Gingival Recession, Tooth Abrasion, Biomaterials
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PR+CAF | Active comparator | Procedure: Restorative procedure, Procedure: Coronally Advanced Flap (CAF)., Drug: Sodium dipyronePartial 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. |
| PR + CAF + VCMX | Experimental | Procedure: Restorative procedure, Procedure: Coronally Advanced Flap (CAF)., Device: Volume-stable collagen matrix (VCMX), Drug: Amoxicillin 500mg, Drug: Sodium dipyronePartial 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restorative procedureUnder 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 or surgery | PR + CAF + VCMX, PR+CAF |
| 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. | Procedure or surgery | PR + CAF + VCMX, PR+CAF |
| 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. | Device | PR + CAF + VCMX |
| Amoxicillin 500mgAlso: Post operative careParticipants enrolled in the PR +CAF+VCMX will be instructed to take amoxicillin 500mg (8 hours/8 hours, during 7 days) after the surgical procedures. | Drug | PR + CAF + VCMX |
| Sodium dipyroneAlso: Post operative careAll participants will be instructed to take 500 mg sodium dipyrone just in case of pain. | Drug | PR + CAF + VCMX, PR+CAF |
Primary outcome
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.
8 secondary outcomes
Dentine hypersensitivity
Time frame: 180 days
Patient-centered esthetic evaluation
Time frame: 180 days
Oral Health Impact Profile
Time frame: 14 days
Patient Discomfort
Time frame: 14 days
Number of analgesics
Time frame: 14 days
Percentage of Complete Combined Defect Coverage (%CDC)
Time frame: 180 days
Modification of the Root Coverage Esthetic Score (MRES)
Time frame: 180 days
Clinical Parameters
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Background: PubMed 33289326Santamaria MP, Miguel MMV, Rossato A, Bonafe ACF, Ferraz LFF, Dos Santos LM, Mathias-Santamaria IF. New Volume-Stable Collagen Matrix and Modified Coronally Advanced Flap to Treat Multiple Gingival Recessions Associated With Partially Restored Non-Carious Cervical Lesions: A Case Report. Clin Adv Periodontics. 2022 Jun;12(2):69-74. doi: 10.1002/cap.10142. Epub 2020 Dec 16.
- Background: PubMed 34586210Santamaria MP, Mathias-Santamaria IF, Ferraz LFF, Casarin RCV, Romito GA, Sallum EA, Pini-Prato GP, Casati MZ. Rethinking the decision-making process to treat gingival recession associated with non-carious cervical lesions. Braz Oral Res. 2021 Sep 24;35(Supp 2):e096. doi: 10.1590/1807-3107bor-2021.vol35.0096. eCollection 2021.
- Background: PubMed 27834120Santamaria MP, Fernandes-Dias SB, Araujo CF, Lucas da Silva Neves F, Mathias IF, Rebelato Bechara Andere NM, Neves Jardini MA. 2-Year Assessment of Tissue Biostimulation With Low-Level Laser on the Outcomes of Connective Tissue Graft in the Treatment of Single Gingival Recession: A Randomized Clinical Trial. J Periodontol. 2017 Apr;88(4):320-328. doi: 10.1902/jop.2016.160391. Epub 2016 Nov 11.
- Background: PubMed 17309597de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. doi: 10.1111/j.1600-051X.2006.01039.x.
- Results publication: PubMed 34310715Mathias-Santamaria IF, Silveira CA, Rossato A, Sampaio de Melo MA, Bresciani E, Santamaria MP. Single gingival recession associated with non-carious cervical lesion treated by partial restoration and coronally advanced flap with or without xenogenous collagen matrix: A randomized clinical trial evaluating the coverage procedures and restorative protocol. J Periodontol. 2022 Apr;93(4):504-514. doi: 10.1002/JPER.21-0358. Epub 2021 Aug 21.
- Results publication: PubMed 32361892Stefanini M, Mounssif I, Barootchi S, Tavelli L, Wang HL, Zucchelli G. An exploratory clinical study evaluating safety and performance of a volume-stable collagen matrix with coronally advanced flap for single gingival recession treatment. Clin Oral Investig. 2020 Sep;24(9):3181-3191. doi: 10.1007/s00784-019-03192-5. Epub 2020 May 2.
- Derived from this study: PubMed 40838330Santamaria MP, Miguel MMV, Rossato A, Bonafe ACF, de Souza IV, Martins TM, Nunes MP, Mathias-Santamaria IF. Volume-stable collagen matrix to treat gingival recession associated with non-carious cervical lesions: Randomized clinical trial. J Periodontol. 2026 Jan;97(1):62-73. doi: 10.1002/jper.11386. Epub 2025 Aug 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restorative procedure, Coronally Advanced Flap (CAF). and Volume-stable collagen matrix (VCMX) in people with Gingival Recession, Localized and Tooth Abrasion, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
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 5 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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mauro P Santamaria, PhD ((12) 39479055 ext. +55, mauro.santamaria@unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recession reduction (RecRed) (time frame: 180 days). 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 NCT05916716, which also lists 7 linked publications.
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 23 Jun 2023.