Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04888676 |
| Other study ID # |
cons21 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2021 |
| Est. completion date |
May 15, 2023 |
Study information
| Verified date |
October 2022 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will be conducted to evaluate and compare the clinical performance of Self-
Adhesive Bulk fill Resin Composite Versus Conventionally Bonded Bulk fill resin composite in
Restoration of Proximal Lesions Over a Period of 18 months Follow-up
Examination and selection of all patients will be done according to inclusion and exclusion
criteria.A Class II cavity will be prepared after local anesthesia has been given as
required. Sectional matricing and wedging will be done. Followed by, placement of restorative
material according to the randomization sequence,. For the intervention: The sectional matrix
will be applied first , followed by filling of cavity with Advanced Self- Adhesive bulk-fill
Resin Composite. (Surefil one™ ,Dentsupply Sirona) in increments of 3-4mm,For the control
group:
The sectional matrix will be applied first , followed by filling of cavity with bulk-fill
resin composite material (GrandioSO x-tra® bulk) in increments of 3-4mm,Clinical evaluation
will be done using using USPHS criteria at 6,12 and 18 months follow up.
Description:
A) Participants, interventions & outcomes 9. Study setting Study will be conducted in the
Conservative Dentistry Department, Faculty of Dentistry - Cairo University.
10. Eligibility criteria 10.a.1 Inclusion criteria:
Patient-related criteria:
- Patients consulting in one of the outpatient clinics listed above.
- Able to tolerate necessary restorative procedures.
- Provide informed consent.
- Accepts the 18 months follow-up period.
Tooth related criteria:
• Teeth with primary proximal carious lesions .
- Teeth are vital according to pulp-sensitivity tests. 10.a.2 Exclusion criteria
Patient-related criteria:
- Medically compromised patients, as they will not be able to attend multiple appointments
or may require special management.
- Pregnant women; as radiographs cannot be taken for them.
- Allergy to any of the restorative materials, including anesthetics.
- Uncooperative patients, will not abide by the instructions or attend the appointments.
Tooth related criteria:
• Deciduous teeth; as the study is targeting only permanent teeth.
- Teeth with previous restorations, which may add another variable to the study (type of
old restorative material, extent of recurrent caries).
- Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests),
which would indicate irreversible pulpal damage.
- Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or
lateral percussion, which would indicate pulp necrosis.
- Teeth presenting external or internal resorption, with adverse pulpal reactions which
may affect the outcome of the study.
- Teeth with cervical caries; which can't be evaluated on periapical radiographs. 11.
Interventions 11.a. Examination and diagnosis: Examination and selection of all patients
will be done according to inclusion and exclusion criteria. Diagnosis of patients' chief
complaint and teeth that will be involved in this study will be done. Teeth are to be
chosen according to standardized radiographic examination. Teeth should have proximal,
primary carious lesions .
11.b. Cavity preparation procedure: A Class II cavity will be prepared after local
anesthesia has been given as required. The cavity will be prepared using a high-speed
hand-piece with air and water coolant and diamond burs of different sizes. Sharp
excavators will allow accessible removal of soft carious lesions will be used. Any tooth
that will suffer from pulpal exposure will be excluded from the study. Finishing of the
cavity walls will be done using a fine-grit, yellow coded, diamond bur.
11.c. Isolation: Rubber dam isolation will be done. 11.d. Matricing and wedging:
Sectional matricing and wedging will be done. Followed by, placement of restorative
material according to the randomization sequence.
11.e. For the intervention: The sectional matrix will be applied first , followed by
filling of cavity with Advanced Self- Adhesive bulk-fill Resin Composite. (Surefil one™
,Dentsupply Sirona) in increments of 3-4mm, as required to end up with leaving an
occlusal space on top of at least 2mm. Finally finishing and occlusal adjustment will be
done under water spray by using superfine diamond burs. Polishing will be done using
pre-impregnated rubber cups. Materials will be manipulated according to manufacturer
instructions.
11.f. For the control group: The sectional matrix will be applied first , followed by
filling of cavity with bulk-fill resin composite material (GrandioSO x-tra® bulk) in
increments of 3-4mm, as required to end up with leaving an occlusal space on top of at
least 2mm. Finally finishing and occlusal adjustment will be done under water spray by
using superfine diamond burs. Polishing will be done using pre-impregnated rubber cups.
Materials will be manipulated according to manufacturer instructions.
11.g. Intervention modification: Restoration will be removed when there are any signs of
leakage, fracture or severe post-operative pain due to pulpal response.
11.h. Intervention adherence: The patients' understanding of their conditions and
treatments, and the amount of information given to the patient is positively related to
adherence to the study and instructions given. Thus, the operator (M.S.) will inform the
participants about all steps from the beginning to the end and explain the importance of
restoring their teeth with such esthetic restorative materials, following instructions,
attending follow up visits and how to maintain good oral hygiene. This will be done
using simple oral conversation, emphasized by written and illustrated material whenever
possible. Oral hygiene of the participants will be enhanced before intervention and any
other chief and subsidiary complaint will be managed in order to modify their behavior.
12. Outcomes: Clinical evaluation using USPHS criteria. 14. Sample Size : We are
planning a study of independent cases and controls. Sample size was calculated based on
the previous study by Guney et al in 2020. Prior data indicated that the probability of
score A for marginal adaptation for bulk fill composite was 0.861 and score B was 0.139
with effect size w 0.722 (n=16). If the estimated probability of score A for marginal
adaptation for self adhesive restorative material is 0.85 and score B is 0.15 with
effect size w 0.7 (n=17), we will need to study a total of 33 restorations to be able to
reject the null hypothesis that the success rates for case and controls are equal with
probability (power) 0.8. This was increased to 40 subjects, 20 in each group to
compensate for losses during follow up. The type I error probability associated with
this test of this null hypothesis is 0.05. Sample size was calculated using G*Power
version 3.1.9.2 for windows using chi-square test 15. Recruitment: Patients will be
recruited by the principle investigator (M.S.) from outpatient clinic of conservative
dentistry department in Faculty of Dentistry, Cairo University; from which eligible
patients will be recruited to fulfill the eligibility criteria according to participant
timeline.
B) Assignment of interventions 16. Allocation - sequence generation 16.a. Random sequence
generation (Randomization): Simple randomization will be assigned for participants by
generating numbers from 1:48 using Random Sequence Generator, Randomness and Integrity
Services Ltd (https://www.random.org/) by D.K. . Each generated random number will represent
assigning both intervention and comparator to each patient in a random manner.
16.b. Allocation concealment mechanism: The restorative technique will be selected according
to randomized numbers in a sealed envelope.
16.c. Implementation: Randomization will be performed by D.K. 17. Blinding Double Blinded;
The participants Participants will be blinded to the technique used, since the patient will
attend the same number of visits and he can not differentiate between different restorative
materials.
Blinding of the operator The operator cannot be blinded because of the use of different
restorative materials applied in each group.
The outcome assessor The outcome assessor will be blinded to the material used. This will be
performed by M.A. and Y.H. Therefore it is necessary that the assessors won't be included in
the preclinical assessment.
C) Data collection, management and analysis 18. Data collection methods 18.a. Data collection
methods: 18.a.i. Baseline data collection: For every patient, medical and dental history will
be taken. Examination charts will be filled by M.S.
18.a.ii. Outcome data collection: Modified USPHS criteria for dental restoration will be
evaluated by two assessors (M.A & Y.H) at baseline, after 6 ,12 and 18 months, if both
assessors differ in score, they will discuss the outcome, if they did not agree, a third
assessor (D.M) will resolve the conflict. To achieve inter-examiners reliability, at the
beginning of the study, the assessors will perform a profound assessment training program by
performing repeated assessments of 36 proximal surface restorations using modified USHPS
criteria. The main supervisor (O.S.) will supervise the training program to ensure that the
assessors (M.A & Y.H.) will be calibrated before starting their evaluation.
18.b. Patient retention: A record of patient's phone number will be included in every
patient's chart. Phone call will be diverted to each patient in order to remind him/her for
the time of his/her visit (M.S.). If the patient did not reply for any reason, another visit
will be scheduled within a week.
19. Data management: Data entry will be carried out by M.S. and revised by D.M. . All data
will be stored on computer and will be encrypted using a password. This will be done to allow
accurate data entry through revision and protect data from being incorrectly used. Data will
be backed up on another storage device to prevent it from being lost.
20. Statistical methods: Data will be analyzed using IBM SPSS advanced statistics
(Statistical Package for Social Sciences), version 25 (SPSS Inc., Chicago, IL).Categorical
data will be described as absolute risk for each intervention independently and relative risk
when comparing both interventions. Comparisons between categorical variables will be
performed using the chi square test. A p-value less than or equal to 0.05 will be considered
statistically significant and all tests will be two tailed. Statistical power of the study
will be set at 80 % with 95 % confidence level.
D) Data monitoring:
21. Monitoring: The main supervisor (O.S.) will monitor this study. Her role is to monitor
any risk of bias could be done from participants, operator or assessors. Also to monitor
blinding of the assessors and patient safety, outstanding benefits or harms.
22. Harms: The principle investigator (M.S.) should inform participants about the possible
harms (pain, loss of restoration, leakage and fracture of restorations) if present.
Participants are allowed to contact the operator at moment through telephone. For assessment
radiograph, inspection, percussion and sensitivity tests will be performed. The data will be
reported to the co-supervisor (D.M.) and managed through removal of restoration, alleviation
of pain and replacement with control restoration.
23. Auditing: In the present trial, auditing will be done by the main supervisors and
co-supervisors (O.S. and D.M.) to assure quality of the research methods, restorative
technique and interventions.
Section IV:
Ethics and dissemination. 24. Research ethics approval: Application forms for carrying out
the clinical trial, checklist and informed consent of Research Ethics Committee (REC) Faculty
of Dentistry, Cairo University will be retrieved and filled, then will be delivered for REC
committee for approval, this is done to prevent any ethical problems during the study or any
harm for any of the participants.
25. Protocol amendments: If a new protocol will be used a protocol amendment will be
submitted; containing a new copy of the new protocol and brief explanation about the
differences between it and the previous protocols. If there is a change in the existing
protocol that affects safety of subjects, investigation scope or scientific quality of the
trial, an amendment containing a brief explanation about the change will be submitted. If a
new author will be added to accomplish the study, an amendment including the investigator's
data and qualifications to conduct the investigation will be submitted to prevent ghost
authorship.
26. Consent: Researcher (M.S.) will introduce the trial to patients and provide full
explanation of its aim and benefits in plain language. Patients will then be able to have an
informed discussion with the researcher. Researcher will obtain written consent from patients
willing to participate in the trial. All, consent forms have been translated into Arabic.
27. Confidentiality: Name and personal data of the participants will not appear on the
protocol form and will be maintained secured for 10 years after the trial. This is done for
protection of participants' privacy and civil rights.
28. Declaration of interests: There is no conflict of interest, no funding or material
supplying from any parties.
29. Access to data: Access to final data will be allowed to the operator M.S. and main and
co- supervisors (O.S. and D.M.) of the study who are not involved in assessment of the
outcome.
30. Ancillary and post-trial care: Patients will be followed up after restoration to ensure
oral hygiene measures. When there is any evidence of restoration failure, patients will be
treated by immediate restoration removal and control restoration placement.
31. Dissemination policy:
- Full protocol will be published online in Clinicaltrials.gov to avoid repetition, and
keep the integrity of the research work.
- Thesis will be discussed and defended in front of a judgment committee.
- The study will be published to report the results of this clinical trial.
