Adhesive SystemNCT06899386
Evaluation Of the BEAUTIBOND XTREME Adhesive in Class I and II Restorations: One-Year Results.
A study testing Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LS, Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS: and Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LS in people with Adhesive System, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This randomized clinical trial aimed to evaluate the performance of the Beautibond Xtreme adhesive system under different bonding techniques. Patients over 18 years old with restorative needs were selected, and 152 teeth were randomized using the "Research Randomizer Program" for allocation into control groups (CI … Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive System
- What is being tested?
- Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LS, Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS: and Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2023to 1 Apr 2024
- 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
- Adults aged 18 years or older
- Occlusal stability supported by molars, Presence of at least one premolar or one molar with Class I/II cavities suitable for direct restoration or restoration replacement
- Ability to attend evaluation and regular maintenance appointments
- No clinical symptoms or radiographic signs suggesting pulp involvement
- No periodontal pockets or compromised biological space invasion
- Ability to perform absolute isolation of the operative field and subsequent restoration of the cavity with composite resin
Show all 9Show fewer
- Active carious lesion
- Occlusal/occlusoproximal surface of molars and premolars, with a radiographic image showing shallow, medium, or deep dentin involvement, which is preventing the patient from effectively controlling bacterial biofilm, or showing some type of sensitivity
- Cavity preparation margins (cavosurface) in enamel or dentin.
Who cannot join
- Poor oral hygiene control
- Patients undergoing orthodontic treatment
- Pregnant or lactating women
- Oral complications such as: bruxism, other parafunctional habits reinforcing the diagnosis of TMD (temporomandibular disorders), periodontal problems
- Pregnant or breastfeeding women
- Presence of uncontrolled systemic diseases
- Patients at high risk for caries.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ribeirão Preto School of Dentistry of the University of São Paulo (FORP-USP)
Ribeirão Preto, São Paulo, 14040-904
About this study
Official title: A Randomized Prospective Clinical Study Evaluating the Effectiveness of the BEAUTIBOND XTREME Adhesive System Using Different Bonding Techniques in Class I and II Restorations: One-Year Results.
This randomized clinical trial aimed to evaluate the performance of the Beautibond Xtreme adhesive system under different bonding techniques. Patients over 18 years old with restorative needs were selected, and 152 teeth were randomized using the "Research Randomizer Program" for allocation into control groups (CI - Class I restoration with total-etch conditioning; CII - Class II restoration with total-etch conditioning) and test groups (TI - Class I restoration in self-etch mode; TII - Class II restoration in self-etch mode; TIII - Class I restoration with selective enamel etching; TIV - Class II restoration with selective enamel etching). The restorations were evaluated (USPHS criteria) regarding anatomy, integrity, marginal staining, color, roughness, secondary caries lesions, postoperative sensitivity, and retention. Two calibrated examiners (Kappa test 0.84), blinded to the treatments, conducted evaluations for up to one year.
- Conditions
- Adhesive System
- Being tested
- Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LS, Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS:, Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LS
- Keywords
- adhesive system, randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LSOther
Also called total-etch technique
the enamel was etched for 30 seconds and the dentin for 15 seconds using 35% phosphoric acid gel (Ultradent). The acid was then rinsed off, and excess moisture was removed with an air spray. To protect the dentin during air blasting, an absorbent paper was held over it using clinical tweezers, ensuring a whitish appearance for the enamel and slightly moist dentin. Excess water on the cotton roll was dried as well. The BeautiBond Xtreme adhesive system was applied without any waiting time, followed by a gentle air spray for 3 seconds and then a strong air blast to ensure solvent evaporation. Finally, the adhesive was light-cured for 5 seconds using a LED photopolymerizer (Gran Valo LED Curing Light, Ultradent).
Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS:Other
Also called self-etch technique
no acid etching was performed on either the enamel or dentin. The BeautiBond Xtreme adhesive system was applied immediately, without any waiting time, followed by a gentle air spray for 3 seconds and then a strong air blast to ensure solvent evaporation. The adhesive was then light-cured for 5 seconds using a LED photopolymerizer (Gran Valo LED Curing Light, Ultradent).
Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LSOther
Also called selective acid-etch technique
the enamel was etched for 15 seconds using 35% phosphoric acid gel (Ultradent). The acid was then rinsed off, and excess moisture was removed with an air spray, leaving the enamel with a whitish appearance. Excess water on the cotton roll was also dried. Next, the BeautiBond Xtreme adhesive system was applied immediately, without any waiting time, followed by a gentle air spray for 3 seconds and then a strong air blast to ensure solvent evaporation. The adhesive was then light-cured for 5 seconds using a LED photopolymerizer (Gran Valo LED Curing Light, Ultradent).
| Study group | Role | What they receive |
|---|---|---|
| CI: Class I cavities restored with the total acid-etching technique. | Experimental | Class I cavities restored with the total acid-etching technique. Receives: Other: Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LS |
| CII: Class II cavities restored with the total acid-etching technique. | Experimental | Class II cavities restored with the total acid-etching technique. Receives: Other: Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LS |
| TI: Class I cavities restored with the self-etching technique. | Experimental | Class I cavities restored with the self-etching technique. Receives: Other: Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS: |
| TII: Class II cavities restored with the self-etching technique. | Experimental | Class II cavities restored with the self-etching technique. Receives: Other: Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS: |
| TIII: Class I cavities restored with the select-etching technique. | Experimental | Class I cavities restored with the select-etching technique Receives: Other: Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LS |
| TIV: Class II cavities restorCed with the select-etching technique. | Experimental | Class II cavities restorCed with the select-etching technique. Receives: Other: Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic Form
The anatomic form of the restoration was evaluated according to the modified United States Public Health Service (USPHS) criteria at baseline, six months, and one year. Restorations were classified as Alpha (continuity of the restoration with the existing anatomic form), Bravo (continuity of the restoration with partial degradation but clinically acceptable), or Charlie (continuity of the restoration compromised, requiring replacement).
Measured: baseline, six months, and one year.
Marginal Adaptation
Marginal adaptation was visually analyzed using an explorer to detect crevices or marginal failures. Classifications included Alpha (no visible evidence of a crevice along the margin), Bravo (visible evidence of a crevice along the margin where the explorer can penetrate or catch), and Charlie (the explorer penetrates the crevice, exposing dentin or base).
Measured: baseline, six months, and one year.
Marginal Discoloration
Marginal discoloration was assessed by recording any color changes at the interface between the restoration and tooth structure. Restorations were classified as Alpha (no visible discoloration), Bravo (discoloration present but not penetrating along the margin in a pulpal direction), or Charlie (deep discoloration penetrating along the margin toward the pulp).
Measured: baseline, six months, and one year.
Secondary Caries
The presence of secondary caries was clinically and radiographically evaluated throughout the study. Restorations were classified as Alpha (no evidence of secondary caries) or Charlie (evidence of secondary caries around the restoration, requiring replacement).
Measured: baseline, six months, and one year.
Color Match
Color match was evaluated by comparing the restoration to the adjacent tooth structure in terms of color and translucency. Classifications included Alpha (color and translucency compatible with the tooth structure), Bravo (color and translucency mismatch within the acceptable range), and Charlie (color and translucency mismatch outside the acceptable range).
Measured: baseline, six months, and one year.
Postoperative Sensitivity
Postoperative sensitivity was assessed through patient reports at different study periods. Classifications included Alpha (no postoperative sensitivity after the restorative procedure and throughout the study), Bravo (slight sensitivity at any stage of the study), and Charlie (severe sensitivity at any stage of the study).
Measured: baseline, six months, and one year.
Surface Texture
The surface texture of the restoration was visually and tactilely evaluated using an explorer. Restorations were classified as Alpha (no surface defects), Bravo (minimal surface defects), or Charlie (severe surface defects on the restoration).
Measured: baseline, six months, and one year.
Retention
Retention was evaluated by verifying the presence of the restoration over time. Classifications included Alpha (no loss of restorative material) and Charlie (fracture and/or total loss of the restorative material).
Measured: baseline, six months, and one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Apr 2023
- Primary completion1 Oct 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive SystemStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larissa Fernanda Pereira, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899386
- Sponsor's protocol ID
- 61246422.4.0000.5498
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Clinical Study Evaluating the Effectiveness of the BEAUTIBOND XTREME Adhesive System Using Different Bonding Techniques in Class I and II Restorations: One-Year Results.
- ClinicalTrials.gov ID
- NCT06899386
- Acronym / sponsor ID
- 61246422.4.0000.5498
- Conditions
- Adhesive System
- Keywords
- adhesive system, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 28 Mar 2025 (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.
This randomized clinical trial aimed to evaluate the performance of the Beautibond Xtreme adhesive system under different bonding techniques. Patients over 18 years old with restorative needs were selected, and 152 teeth were randomized using the "Research Randomizer Program" for allocation into control groups (CI - Class I restoration with total-etch conditioning; CII - Class II restoration with total-etch conditioning) and test groups (TI - Class I restoration in self-etch mode; TII - Class II restoration in self-etch mode; TIII - Class I restoration with selective enamel etching; TIV - Class II restoration with selective enamel etching). The restorations were evaluated (USPHS criteria) regarding anatomy, integrity, marginal staining, color, roughness, secondary caries lesions, postoperative sensitivity, and retention. Two calibrated examiners (Kappa test 0.84), blinded to the treatments, conducted evaluations for up to one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CI: Class I cavities restored with the total acid-etching technique. | Experimental | Other: Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LSClass I cavities restored with the total acid-etching technique. |
| CII: Class II cavities restored with the total acid-etching technique. | Experimental | Other: Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LSClass II cavities restored with the total acid-etching technique. |
| TI: Class I cavities restored with the self-etching technique. | Experimental | Other: Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS:Class I cavities restored with the self-etching technique. |
| TII: Class II cavities restored with the self-etching technique. | Experimental | Other: Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS:Class II cavities restored with the self-etching technique. |
| TIII: Class I cavities restored with the select-etching technique. | Experimental | Other: Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LSClass I cavities restored with the select-etching technique |
| TIV: Class II cavities restorCed with the select-etching technique. | Experimental | Other: Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LSClass II cavities restorCed with the select-etching technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults aged 18 years or older
- Occlusal stability supported by molars, Presence of at least one premolar or one molar with Class I/II cavities suitable for direct restoration or restoration replacement
- Ability to attend evaluation and regular maintenance appointments
- No clinical symptoms or radiographic signs suggesting pulp involvement
- No periodontal pockets or compromised biological space invasion
Key exclusion criteria (7 listed)
- Poor oral hygiene control
- Patients undergoing orthodontic treatment
- Pregnant or lactating women
- Oral complications such as: bruxism, other parafunctional habits reinforcing the diagnosis of TMD (temporomandibular disorders), periodontal problems
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LSAlso: total-etch techniquethe enamel was etched for 30 seconds and the dentin for 15 seconds using 35% phosphoric acid gel (Ultradent). The acid was then rinsed off, and excess moisture was removed with an air spray. To protect the dentin during air blasting, an absorbent paper was held over it using clinical tweezers, ensuring a whitish appearance for the enamel and slightly moist dentin. Excess water on the cotton roll was dried as well. The BeautiBond Xtreme adhesive system was applied without any waiting time, followed by a gentle air spray for 3 seconds and then a strong air blast to ensure solvent evaporation. Finally, the adhesive was light-cured for 5 seconds using a LED photopolymerizer (Gran Valo LED Curing Light, Ultradent). | Other | CI: Class I cavities restored with the total acid-etching technique., CII: Class II cavities restored with the total acid-etching technique. |
| Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS:Also: self-etch techniqueno acid etching was performed on either the enamel or dentin. The BeautiBond Xtreme adhesive system was applied immediately, without any waiting time, followed by a gentle air spray for 3 seconds and then a strong air blast to ensure solvent evaporation. The adhesive was then light-cured for 5 seconds using a LED photopolymerizer (Gran Valo LED Curing Light, Ultradent). | Other | TI: Class I cavities restored with the self-etching technique., TII: Class II cavities restored with the self-etching technique. |
| Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LSAlso: selective acid-etch techniquethe enamel was etched for 15 seconds using 35% phosphoric acid gel (Ultradent). The acid was then rinsed off, and excess moisture was removed with an air spray, leaving the enamel with a whitish appearance. Excess water on the cotton roll was also dried. Next, the BeautiBond Xtreme adhesive system was applied immediately, without any waiting time, followed by a gentle air spray for 3 seconds and then a strong air blast to ensure solvent evaporation. The adhesive was then light-cured for 5 seconds using a LED photopolymerizer (Gran Valo LED Curing Light, Ultradent). | Other | TIII: Class I cavities restored with the select-etching technique., TIV: Class II cavities restorCed with the select-etching technique. |
Primary outcome
Anatomic Form
Time frame: baseline, six months, and one year.
The anatomic form of the restoration was evaluated according to the modified United States Public Health Service (USPHS) criteria at baseline, six months, and one year. Restorations were classified as Alpha (continuity of the restoration with the existing anatomic form), Bravo (continuity of the restoration with partial degradation but clinically acceptable), or Charlie (continuity of the restoration compromised, requiring replacement).
Marginal Adaptation
Time frame: baseline, six months, and one year.
Marginal adaptation was visually analyzed using an explorer to detect crevices or marginal failures. Classifications included Alpha (no visible evidence of a crevice along the margin), Bravo (visible evidence of a crevice along the margin where the explorer can penetrate or catch), and Charlie (the explorer penetrates the crevice, exposing dentin or base).
Marginal Discoloration
Time frame: baseline, six months, and one year.
Marginal discoloration was assessed by recording any color changes at the interface between the restoration and tooth structure. Restorations were classified as Alpha (no visible discoloration), Bravo (discoloration present but not penetrating along the margin in a pulpal direction), or Charlie (deep discoloration penetrating along the margin toward the pulp).
Secondary Caries
Time frame: baseline, six months, and one year.
The presence of secondary caries was clinically and radiographically evaluated throughout the study. Restorations were classified as Alpha (no evidence of secondary caries) or Charlie (evidence of secondary caries around the restoration, requiring replacement).
Color Match
Time frame: baseline, six months, and one year.
Color match was evaluated by comparing the restoration to the adjacent tooth structure in terms of color and translucency. Classifications included Alpha (color and translucency compatible with the tooth structure), Bravo (color and translucency mismatch within the acceptable range), and Charlie (color and translucency mismatch outside the acceptable range).
Postoperative Sensitivity
Time frame: baseline, six months, and one year.
Postoperative sensitivity was assessed through patient reports at different study periods. Classifications included Alpha (no postoperative sensitivity after the restorative procedure and throughout the study), Bravo (slight sensitivity at any stage of the study), and Charlie (severe sensitivity at any stage of the study).
Surface Texture
Time frame: baseline, six months, and one year.
The surface texture of the restoration was visually and tactilely evaluated using an explorer. Restorations were classified as Alpha (no surface defects), Bravo (minimal surface defects), or Charlie (severe surface defects on the restoration).
Retention
Time frame: baseline, six months, and one year.
Retention was evaluated by verifying the presence of the restoration over time. Classifications included Alpha (no loss of restorative material) and Charlie (fracture and/or total loss of the restorative material).
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 28 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group CI and CII - BeautiBond Xtreme (total-etch technique) + Beautifil LS, Group TI and TII - BeautiBond Xtreme (self-etch technique) + Beautifil LS: and Group TIII and TIV - BeautiBond Xtreme (selective acid-etch technique) + Beautifil LS in people with Adhesive System, run by University of Sao Paulo 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 9 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 28 Mar 2025. 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?
Anatomic Form (time frame: baseline, six months, and one year.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2025.