Dental AbrasionNCT03215615

Evaluation of Two Resin Composites and Two Adhesives for a Novel Restorative Protocol to Treat Cervical Lesions

A study testing Periodontal surgery, Total Etch adhesive and Universal Adhesive in people with Dental Abrasion and Gingival Recession, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Dental Abrasion, Gingival Recession, Composite Resins
What is being tested?: Periodontal surgery, Total Etch adhesive and Universal Adhesive
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteBrazil
Study dates: Nov 2016to Jun 2019
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Individuals presenting one or more combined defect, i.e. a NCCL classified as B+ (Pini-Prato et al., 2010): presenting more than 1mm in depth, affecting dental crown and root associated with Miller's class I or II gingival recession in canines or premolars with pulp vitality;
Healthy patients (systemically and periodontally), 18 years old, with at least 20 teeth in occlusion;
Plaque index ≤ 20% (Ainamo \& Bay, 1975);
NCCL cavo-surface margin without involvement of more than 50% of enamel;
In tooth included in the study and the adjacent elements of the following must be observed: probing depth less than 3 mm; do not show bleeding on probing (periodontal health) and no insertion loss in the proximal and palatal areas; Provide formal consent to participate in research, after the explanation of the risks and benefits by an individual not involved in it (Resolution #196 October 1996 and the Code of Dental Professional Ethics - C.F.O. - 179/93).

Who cannot join

NCCL previously restored;
Presence of caries;
Patients with periodontitis;
Patients with bruxism or teeth clenching;
Patients with orthodontic treatment in progress;
Pregnant patients or smokers;
Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, diabetes and others), which contraindicate the surgical procedure; Previous periodontal surgery in the area of interest of the present study.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

UEPJMF
São José dos Campos, São Paulo, 12245000

Other trials in Brazil

About this study

Official title: Evaluation of Two Resin Composites and Two Adhesives for a Novel Surgical-restorative Protocol for the Treatment of Non-carious Cervical Lesions Associated With Gingival Recession: a Randomized Controlled Clinical Trial

Non-carious cervical lesion is frequently associated with gingival recession, resulting in a combined lesion that has a different treatment prognosis when the two lesions appear alone. The literature presents few studies that propose a multidisciplinary approach (restorative and root coverage surgery procedures) to optimize the treatment of this combined lesion. The previously proposed approaches and materials have limitations and an optimal clinical protocol has not been established yet. Thus the aim of this study is to evaluate a novel multidisciplinary protocol with two resin composites and two different adhesive systems through a randomized clinical trial and laboratory studies. 120 combined lesions will be randomly assigned to one of the following groups: NP + TE (n = 30) - Partial restoration of cervical lesions with nanofilled composite and total-etch adhesive system and periodontal surgery for root coverage, NP + UA (n = 30) - partial restoration of cervical lesions with nanofilled composite and self-etching adhesive system and periodontal surgery for root coverage, MH + TE (n = 30) - partial restoration of cervical lesions with microhybrid composite and total-etch adhesive system and periodontal surgery for root coverage, MH + UA (n = 30) - partial restoration of cervical lesions with microhybrid composite and self-etching adhesive system and periodontal surgery for root coverage. Restorations will be assessed using the USPHS criteria after one week, six months and twelve months.

Conditions: Dental Abrasion, Gingival Recession, Composite Resins
Being tested: Periodontal surgery, Total Etch adhesive, Universal Adhesive, Nanofilled Composite, Micro-Hybrid Composite
Medical subject headings: Tooth Abrasion, Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Periodontal surgeryProcedure or surgery
Coronally advanced flap for root coverage
Total Etch adhesiveProcedure or surgery
Total-etch adhesive system (two step)
Universal AdhesiveProcedure or surgery
One-step self-etching adhesive system
Nanofilled CompositeProcedure or surgery
Partial nanofilled-resin composite restoration
Micro-Hybrid CompositeProcedure or surgery
Partial micro-hybrid composite restoration

Study groups in NCT03215615
Study group	Role	What they receive
Group NF + TE	Active comparator	Nanofilled Composite - Filtek Z350 XT® - 3M ESPE (NF) + Total Etch adhesive - Adper Single Bond 2® - 3M ESPE (TE) adhesive: combined lesions will be treated with partial restoration with nanofilled resin composite and total-etch adhesive system (two step). Subsequently, periodontal surgery will be performed for root coverage. Receives: Procedure: Periodontal surgery; Procedure: Total Etch adhesive; Procedure: Nanofilled Composite
Group NF + UA	Active comparator	Nanofilled Composite - Filtek Z350 XT® - 3M ESPE (NF) + Universal Adhesive - Single Bond Universal® - 3M ESPE (UA): combined lesions will be treated with partial restoration with nanofilled resin composite and one-step self-etching adhesive system. Subsequently, periodontal surgery will be performed for root coverage. Receives: Procedure: Periodontal surgery; Procedure: Universal Adhesive; Procedure: Nanofilled Composite
Group MH + TE	Active comparator	Micro-Hybrid Composite - Charisma Classic® - Heraeus Kulzer (MH) + Total Etch adhesive - Adper Single Bond 2® - 3M ESPE (TE) adhesive: combined lesions will be treated with partial restoration with micro-hybrid resin composite and total-etch adhesive system (two step). Subsequently, periodontal surgery will be performed for root coverage. Receives: Procedure: Periodontal surgery; Procedure: Total Etch adhesive; Procedure: Micro-Hybrid Composite
Group MH + UA	Active comparator	Micro-Hybrid Composite - Charisma Classic® - Heraeus Kulzer (MH) + Universal Adhesive - Single Bond Universal® - 3M ESPE (UA): combined lesions will be treated with partial restoration with micro-hybrid resin composite and one-step self-etching adhesive system. Subsequently, periodontal surgery will be performed for root coverage. Receives: Procedure: Periodontal surgery; Procedure: Universal Adhesive; Procedure: Micro-Hybrid Composite

What is being measured

The primary outcome is the main question the study is designed to answer.

Modified United States Public Health Service (USPHS) criteria
USPHS criteria is based on the following ratings: Color compatibility, retention, marginal adaptation, anatomic form, surface texture, marginal discoloration, sensibility pre-operative and postoperative and the presence of secondary caries
Measured: 1 year

Secondary outcomes (2)

Aesthetics (Visual Analogue Acale - VAS)
The esthetics of the treatment will be evaluated by patients´ point of view using the VAS scale
Measured: 1 year
Dentin Hypersensitivity (Visual Analogue Acale - VAS)
The Dentin Hypersensitivity will be evaluated by patients´ point of view using the VAS scale
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Jun 2019

First posted12 Jul 2017
Study startNov 2016
Primary completionJun 2019
Study completionJun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dental AbrasionStudies 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: Factorial
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03215615
Sponsor's protocol ID: 56450116.9.0000.0077
Status last verified: Jun 2019
First submitted: 24 Nov 2016
Last updated: 13 Jun 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Mathias-Santamaria IF, Santamaria MP, Silveira CA, Martinho FC, de Melo MAS, De Marco AC, Augusto MG, de Andrade GS, Roulet JF, Bresciani E. Evaluation of a novel restorative protocol to treat non-carious cervical lesion associated with gingival recession: a 2-year follow-up randomized clinical trial. Clin Oral Investig. 2023 Apr;27(4):1781-1792. doi: 10.1007/s00784-022-04806-1. Epub 2022 Dec 3.
PubMed 36462038

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Two Resin Composites and Two Adhesives for a Novel Surgical-restorative Protocol for the Treatment of Non-carious Cervical Lesions Associated With Gingival Recession: a Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT03215615
Acronym / sponsor ID: 56450116.9.0000.0077
Conditions: Dental Abrasion, Gingival Recession, Composite Resins
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
Study start: Nov 2016
Primary completion: Jun 2019 (actual)
Study completion: Jun 2019 (actual)
First posted: 12 Jul 2017 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group NF + TE	Active comparator	Procedure: Periodontal surgery, Procedure: Total Etch adhesive, Procedure: Nanofilled CompositeNanofilled Composite - Filtek Z350 XT® - 3M ESPE (NF) + Total Etch adhesive - Adper Single Bond 2® - 3M ESPE (TE) adhesive: combined lesions will be treated with partial restoration with nanofilled resin composite and total-etch adhesive system (two step). Subsequently, periodontal surgery will be performed for root coverage.
Group NF + UA	Active comparator	Procedure: Periodontal surgery, Procedure: Universal Adhesive, Procedure: Nanofilled CompositeNanofilled Composite - Filtek Z350 XT® - 3M ESPE (NF) + Universal Adhesive - Single Bond Universal® - 3M ESPE (UA): combined lesions will be treated with partial restoration with nanofilled resin composite and one-step self-etching adhesive system. Subsequently, periodontal surgery will be performed for root coverage.
Group MH + TE	Active comparator	Procedure: Periodontal surgery, Procedure: Total Etch adhesive, Procedure: Micro-Hybrid CompositeMicro-Hybrid Composite - Charisma Classic® - Heraeus Kulzer (MH) + Total Etch adhesive - Adper Single Bond 2® - 3M ESPE (TE) adhesive: combined lesions will be treated with partial restoration with micro-hybrid resin composite and total-etch adhesive system (two step). Subsequently, periodontal surgery will be performed for root coverage.
Group MH + UA	Active comparator	Procedure: Periodontal surgery, Procedure: Universal Adhesive, Procedure: Micro-Hybrid CompositeMicro-Hybrid Composite - Charisma Classic® - Heraeus Kulzer (MH) + Universal Adhesive - Single Bond Universal® - 3M ESPE (UA): combined lesions will be treated with partial restoration with micro-hybrid resin composite and one-step self-etching adhesive system. Subsequently, periodontal surgery will be performed for root coverage.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Individuals presenting one or more combined defect, i.e. a NCCL classified as B+ (Pini-Prato et al., 2010): presenting more than 1mm in depth, affecting dental crown and root associated with Miller's class I or II gingival recession in canines or premolars with pulp vitality;
Healthy patients (systemically and periodontally), 18 years old, with at least 20 teeth in occlusion;
Plaque index ≤ 20% (Ainamo \& Bay, 1975);
NCCL cavo-surface margin without involvement of more than 50% of enamel;
In tooth included in the study and the adjacent elements of the following must be observed: probing depth less than 3 mm; do not show bleeding on probing (periodontal health) and no insertion loss in the proximal and palatal areas; Provide formal consent to participate in research, after the explanation of the risks and benefits by an individual not involved in it (Resolution #196 October 1996 and the Code of Dental Professional Ethics - C.F.O. - 179/93).

Key exclusion criteria (7 listed)

NCCL previously restored;
Presence of caries;
Patients with periodontitis;
Patients with bruxism or teeth clenching;
Patients with orthodontic treatment in progress;

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
Periodontal surgeryCoronally advanced flap for root coverage	Procedure or surgery	Group MH + TE, Group MH + UA, Group NF + TE, Group NF + UA
Total Etch adhesiveTotal-etch adhesive system (two step)	Procedure or surgery	Group MH + TE, Group NF + TE
Universal AdhesiveOne-step self-etching adhesive system	Procedure or surgery	Group MH + UA, Group NF + UA
Nanofilled CompositePartial nanofilled-resin composite restoration	Procedure or surgery	Group NF + TE, Group NF + UA
Micro-Hybrid CompositePartial micro-hybrid composite restoration	Procedure or surgery	Group MH + TE, Group MH + UA

Primary outcome

Modified United States Public Health Service (USPHS) criteria
Time frame: 1 year
USPHS criteria is based on the following ratings: Color compatibility, retention, marginal adaptation, anatomic form, surface texture, marginal discoloration, sensibility pre-operative and postoperative and the presence of secondary caries

2 secondary outcomes

Aesthetics (Visual Analogue Acale - VAS)
Time frame: 1 year
Dentin Hypersensitivity (Visual Analogue Acale - VAS)
Time frame: 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
Derived from this study: PubMed 36462038Mathias-Santamaria IF, Santamaria MP, Silveira CA, Martinho FC, de Melo MAS, De Marco AC, Augusto MG, de Andrade GS, Roulet JF, Bresciani E. Evaluation of a novel restorative protocol to treat non-carious cervical lesion associated with gingival recession: a 2-year follow-up randomized clinical trial. Clin Oral Investig. 2023 Apr;27(4):1781-1792. doi: 10.1007/s00784-022-04806-1. Epub 2022 Dec 3.
Individual participant dataSharing planned: Undecided

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.

Eduardo Bresciani, PhD principal investigator

Universidade Estadual Paulista Júlio de Mesquita Filho

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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: finished, as of the sponsor's last update on 13 Jun 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified United States Public Health Service (USPHS) criteria (time frame: 1 year). 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 NCT03215615, which also lists 1 linked publication.

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 13 Jun 2019; AzTrials last refreshed its copy on 6 Nov 2026.