Non-carious Cervical LesionsPhase 2/3NCT01506830
Cervical Restorations Placed Under Two Isolation Methods
A Phase 2/3 study testing Relative isolation with cotton rolls and Absolute isolation with rubber dam in people with Non-carious Cervical Lesions, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
During restorative procedures, different isolation methods of the operative field can be used to promote moisture control and retraction of the gingival tissues. The aim of the present clinical trial is to evaluate the effects of two isolation techniques on the clinical performance of Class V restorations, as well on… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-carious Cervical Lesions
- What is being tested?
- Relative isolation with cotton rolls and Absolute isolation with rubber dam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2009to Dec 2011
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- more than one cervical lesion
- lesions whose apical limit located above the gingival margin
- lesions with at least 1 mm of depth
- vital permanent incisors, canines, or premolars
Who cannot join
- smoking habits
- severe systemic diseases
- active orthodontic treatment
- malocclusion (Angle Class II or Class III)
- less than 20 natural teeth in mouth
- absent of antagonist tooth
Show all 11Show fewer
- wear facets over more than 50% of the incisal/occlusion surface as a result of tooth attrition
- or restorations in the area to be treated
- full-mouth visible plaque index (VPI) or full-mouth gingival bleeding index (GBI) more than 20%
- probing depth (PD) and clinical attachment loss (CAL) values exceeding 4 mm with bleeding on probing (BOP)
- unwillingness to return for follow-ups or refuse to participate
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Pelotas - School of Dentistry
Pelotas, Rio Grande do Sul, 96015560
About this study
Official title: Influence of Operatory Field Isolation Techniques on the Clinical Performance of Class V Restorations
During restorative procedures, different isolation methods of the operative field can be used to promote moisture control and retraction of the gingival tissues. The aim of the present clinical trial is to evaluate the effects of two isolation techniques on the clinical performance of Class V restorations, as well on the periodontal conditions of restored sites. Patients presenting at least two noncarious cervical lesions (NCLs) will be enrolled in this study. The NCLs will be randomized into the following groups: (1) isolation performed with rubber dam and gingival retraction clamp and (2) isolation provided with cotton rolls and gingival retraction cord. Both techniques will be used with a saliva suction device. All restorative procedures were performed using a self-etching adhesive system and a nanofilled composite resin according to the manufacturer's instructions. The clinical performance of restorations will be recorded in terms of fracture and retention of restoration, marginal adaptation, marginal staining, postoperative hypersensitivity, and preservation of tooth vitality at 1 week, 6 months, 12, 24 and 72 months after placement. The periodontal condition of restored sites will be evaluated based on the presence of supragingival plaque, gingival marginal bleeding, probing depth, and relative gingival recession.
- Conditions
- Non-carious Cervical Lesions
- Being tested
- Relative isolation with cotton rolls, Absolute isolation with rubber dam
- Keywords
- Adhesives., Composites., Noncarious cervical lesions., Clinical performance., Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relative isolation with cotton rollsProcedure or surgery
Cotton roll group: Moisture control was provided using a labial retractor, cotton rolls and gingival retraction cord placed into the gingival sulcus
Absolute isolation with rubber damProcedure or surgery
Rubber dam group: Moisture control was provided by a rubber dam and a gingival retraction clamp placed in the cervical area of the tooth.
| Study group | Role | What they receive |
|---|---|---|
| Absolute isolation | Active comparator | Absolute isolation of the operatory field with rubber dam: Moisture control is provided by a rubber dam and a gingival retraction clamp placed in the cervical area of the tooth. Receives: Procedure: Absolute isolation with rubber dam |
| Relative isolation | Experimental | Relative isolation of the operatory field with cotton rolls: Moisture control was provided using a labial retractor, cotton rolls and gingival retraction cord placed into the gingival sulcus Receives: Procedure: Relative isolation with cotton rolls |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention of restorations
Retention of restorations is measured by clinical examination, where each placed restoration is checked and scored as present, partially lost or lost at the recalls.
Measured: up to 72 months
Restorations marginal staining
Restorations are checked during recalls regarding the marginal staining and scored as clinically ideal, clinically acceptable; presence of small ditching; presence of extensive marginal ditching and need for repair /replacement.
Measured: up to 72 months
Secondary outcomes (1)
Periodontal condition of restored sites
The periodontal condition of restored sites is evaluated based on the presence of supragingival plaque, gingival marginal bleeding, probing depth, and relative gingival recession.
Measured: 6, 12, 24, 48 and 72 months after restorations' placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startJul 2009
- Primary completionJul 2011
- Study completionDec 2011
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 Non-carious Cervical LesionsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
- Investigators
- Alexandre S Masotti, PhD, Study chair, Federal University of PelotasFernanda OB Corrêa, PhD, Principal investigator, Federal University of PelotasSilvia T Fontes, PhD, Principal investigator, Federal University of PelotasMaximiliano S Cenci, PhD, Principal investigator, Federal University of PelotasPatricia S Jardim, PhD, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506830
- Sponsor's protocol ID
- UFPEL-PPGO0012
- Status last verified
- Feb 2016
- First submitted
- 30 Dec 2011
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Favetti M, Montagner AF, Fontes ST, Martins TM, Masotti AS, Jardim PDS, Correa FOB, Cenci MS, Muniz FWMG. Effects of cervical restorations on the periodontal tissues: 5-year follow-up results of a randomized clinical trial. J Dent. 2021 Mar;106:103571. doi: 10.1016/j.jdent.2020.103571. Epub 2020 Dec 29.
PubMed 33385534
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Operatory Field Isolation Techniques on the Clinical Performance of Class V Restorations
- ClinicalTrials.gov ID
- NCT01506830
- Acronym / sponsor ID
- UFPEL-PPGO0012
- Conditions
- Non-carious Cervical Lesions
- Keywords
- Adhesives., Composites., Noncarious cervical lesions., Clinical performance., Treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Jan 2012 (estimated)
- 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.
During restorative procedures, different isolation methods of the operative field can be used to promote moisture control and retraction of the gingival tissues. The aim of the present clinical trial is to evaluate the effects of two isolation techniques on the clinical performance of Class V restorations, as well on the periodontal conditions of restored sites. Patients presenting at least two noncarious cervical lesions (NCLs) will be enrolled in this study. The NCLs will be randomized into the following groups: (1) isolation performed with rubber dam and gingival retraction clamp and (2) isolation provided with cotton rolls and gingival retraction cord. Both techniques will be used with a saliva suction device. All restorative procedures were performed using a self-etching adhesive system and a nanofilled composite resin according to the manufacturer's instructions. The clinical performance of restorations will be recorded in terms of fracture and retention of restoration, marginal adaptation, marginal staining, postoperative hypersensitivity, and preservation of tooth vitality at 1 week, 6 months, 12, 24 and 72 months after placement. The periodontal condition of restored sites will be evaluated based on the presence of supragingival plaque, gingival marginal bleeding, probing depth, and relative gingival recession.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absolute isolation | Active comparator | Procedure: Absolute isolation with rubber damAbsolute isolation of the operatory field with rubber dam: Moisture control is provided by a rubber dam and a gingival retraction clamp placed in the cervical area of the tooth. |
| Relative isolation | Experimental | Procedure: Relative isolation with cotton rollsRelative isolation of the operatory field with cotton rolls: Moisture control was provided using a labial retractor, cotton rolls and gingival retraction cord placed into the gingival sulcus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- more than one cervical lesion
- lesions whose apical limit located above the gingival margin
- lesions with at least 1 mm of depth
- vital permanent incisors, canines, or premolars
Key exclusion criteria (11 listed)
- smoking habits
- severe systemic diseases
- active orthodontic treatment
- malocclusion (Angle Class II or Class III)
- less than 20 natural teeth in mouth
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 |
|---|---|---|
| Relative isolation with cotton rollsCotton roll group: Moisture control was provided using a labial retractor, cotton rolls and gingival retraction cord placed into the gingival sulcus | Procedure or surgery | Relative isolation |
| Absolute isolation with rubber damRubber dam group: Moisture control was provided by a rubber dam and a gingival retraction clamp placed in the cervical area of the tooth. | Procedure or surgery | Absolute isolation |
Primary outcome
retention of restorations
Time frame: up to 72 months
Retention of restorations is measured by clinical examination, where each placed restoration is checked and scored as present, partially lost or lost at the recalls.
Restorations marginal staining
Time frame: up to 72 months
Restorations are checked during recalls regarding the marginal staining and scored as clinically ideal, clinically acceptable; presence of small ditching; presence of extensive marginal ditching and need for repair /replacement.
1 secondary outcome
Periodontal condition of restored sites
Time frame: 6, 12, 24, 48 and 72 months after restorations' placement
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 24 Feb 2016.
- Derived from this study: PubMed 33385534Favetti M, Montagner AF, Fontes ST, Martins TM, Masotti AS, Jardim PDS, Correa FOB, Cenci MS, Muniz FWMG. Effects of cervical restorations on the periodontal tissues: 5-year follow-up results of a randomized clinical trial. J Dent. 2021 Mar;106:103571. doi: 10.1016/j.jdent.2020.103571. Epub 2020 Dec 29.
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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.
Alexandre S Masotti, PhD study chair
Federal University of Pelotas
Fernanda OB Corrêa, PhD principal investigator
Federal University of Pelotas
Silvia T Fontes, PhD principal investigator
Federal University of Pelotas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Relative isolation with cotton rolls and Absolute isolation with rubber dam in people with Non-carious Cervical Lesions, run by Federal University of Pelotas 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 4 inclusion and 11 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 24 Feb 2016. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
retention of restorations (time frame: up to 72 months). The study lists 2 primary outcomes in all. 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 NCT01506830, 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 24 Feb 2016.