Periodontal ParametersNCT07196969
Effects of Electric Toothbrushes on Periodontal Health and Oral Microbial Flora in Children With Space Maintainers
A study testing Electric toothbrush and Manual toothbrush in people with Periodontal Parameters and Oral Microbial Colonization, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: To evaluate and compare the effects of electric and manual toothbrushes on periodontal health parameters and salivary microbial flora in children with fixed and removable space maintainers. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Parameters, Oral Microbial Colonization, Periodontal Health
- What is being tested?
- Electric toothbrush and Manual toothbrush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jul 2022to 26 Apr 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-12 years who required a space maintainer due to premature loss of primary molar teeth were included if they were medically healthy; had no periodontal disease, temporomandibular disorders, bruxism, abnormal oral habits, or physical/mental disabilities affecting hand movement; were not on regular medication; had not used antibiotics within the past three months or plaque-preventive agents within the last six months; and were able to comply with scheduled follow-up visits.
Who cannot join
- Patients who failed to attend follow-up appointments or developed an infection/disease requiring antibiotic therapy during the study were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Dentistry
Denizli
About this study
Official title: Effects of Electric and Manual Toothbrushes on Periodontal Health and Oral Microbial Flora in Children With Space Maintainers: A Randomized Controlled Trial
Objectives: To evaluate and compare the effects of electric and manual toothbrushes on periodontal health parameters and salivary microbial flora in children with fixed and removable space maintainers.
Materials and methods: Sixty-eight children (30 girls, 38 boys; mean age 8.8 years) requiring fixed (n=34) or removable (n=34) space maintainers were randomly allocated to electric (n=17) or manual (n=17) toothbrush subgroups. Periodontal indices; plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD) and salivary levels of Streptococcus mutans and Lactobacillus were assessed at baseline (T0), 1 month (T1), and 3 months (T2).
Read the detailed description
A total of 68 patients (thirty girls and thirty-eight boys), aged between 6 and 12 years (mean age 8.8), who received either fixed or removable space maintainers due to premature loss of primary molar teeth, were included in the study.
Patients were randomized into two groups based on the type of space maintainer: fixed (n = 34) or removable (n = 34). Each group was further subdivided according to the type of toothbrush used: manual or electric, resulting in four subgroups (n=17). To standardize the study population, only band-and-loop appliances were used in the fixed space maintainer group, which were cemented using a fluoride-releasing glass ionomer cement (RelyX; 3M ESPE, St. Paul, MN, USA). Removable space maintainers consisted of an acrylic base with retention elements such as Adams' clasps, C clasps, or vestibular archesPatients in the removable space maintainer group were instructed to use their appliances during the day, except while eating and sleeping, and to clean them by brushing after toothbrushing.
- Being tested
- Electric toothbrush, Manual toothbrush
- Keywords
- Electric toothbrush, Manual toothbrush, Periodontal health, Pediatric dentistry, Space maintainers, Salivary microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric toothbrushDevice
Two minutes; twice a day; 3-months.
Manual toothbrushDevice
Two minutes; twice a day; 3-months.
| Study group | Role | What they receive |
|---|---|---|
| Group I: Fixed Space Maintainer with Manual Toothbrush | Other | In this group, patients with fixed space maintainers used manual toothbrushes (Oral-B Cavity Defense; Procter \& Gamble, USA) during study period. Receives: Device: Manual toothbrush |
| Group II: Fixed Space Maintainer with Electric Toothbrush | Experimental | In this group, patients with fixed space maintainers used electric toothbrushes (Oral-B Vitality Cross Action; Procter \& Gamble, USA) during study period. Receives: Device: Electric toothbrush |
| Group III: Removable Space Maintainer with Manual Toothbrush | Other | In this group, patients with removable space maintainers used manual toothbrushes (Oral-B Cavity Defense; Procter \& Gamble, USA) during study period. Receives: Device: Manual toothbrush |
| Group IV: Removable Space Maintainer with Electric Toothbrush | Experimental | In this group, patients with removable space maintainers used electric toothbrushes (Oral-B Vitality Cross Action; Procter \& Gamble, USA) during study period. Receives: Device: Electric toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plaque Index (PI)
Evaluation of plaque index scores using the Modified Silness and Löe Index.
Measured: Baseline (T0), 1 month (T1), and 3 months (T2).
Change in Gingival Index (GI)
Evaluation of gingival index scores using the Gingival Index.
Measured: Baseline (T0), 1 month (T1), and 3 months (T2)
Change in Bleeding on Probing (BOP)
Evaluation of bleeding on probing scores using the Bleeding on Probing (bop) Index
Measured: Baseline (T0), 1 month (T1), and 3 months (T2)
Change in Periodontal Pocket Depth (PPD)
Evaluation of periodontal pocket depth (PPD)
Measured: Baseline (T0), 1 month (T1), and 3 months (T2)
Change in salivary Streptococcus mutans levels
Measured: Baseline (T0), 1 month (T1), and 3 months (T2)
Change in salivary Lactobacillus levels
Measured: Baseline (T0), 1 month (T1), and 3 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start18 Jul 2022
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal ParametersStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arif Bolaca, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196969
- Sponsor's protocol ID
- 2022DİŞF002
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electric and Manual Toothbrushes on Periodontal Health and Oral Microbial Flora in Children With Space Maintainers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07196969
- Acronym / sponsor ID
- 2022DİŞF002
- Keywords
- Electric toothbrush, Manual toothbrush, Periodontal health, Pediatric dentistry, Space maintainers, Salivary microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 29 Sep 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.
Objectives: To evaluate and compare the effects of electric and manual toothbrushes on periodontal health parameters and salivary microbial flora in children with fixed and removable space maintainers.
Materials and methods: Sixty-eight children (30 girls, 38 boys; mean age 8.8 years) requiring fixed (n=34) or removable (n=34) space maintainers were randomly allocated to electric (n=17) or manual (n=17) toothbrush subgroups. Periodontal indices; plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD) and salivary levels of Streptococcus mutans and Lactobacillus were assessed at baseline (T0), 1 month (T1), and 3 months (T2).
Detailed description
A total of 68 patients (thirty girls and thirty-eight boys), aged between 6 and 12 years (mean age 8.8), who received either fixed or removable space maintainers due to premature loss of primary molar teeth, were included in the study.
Patients were randomized into two groups based on the type of space maintainer: fixed (n = 34) or removable (n = 34). Each group was further subdivided according to the type of toothbrush used: manual or electric, resulting in four subgroups (n=17). To standardize the study population, only band-and-loop appliances were used in the fixed space maintainer group, which were cemented using a fluoride-releasing glass ionomer cement (RelyX; 3M ESPE, St. Paul, MN, USA). Removable space maintainers consisted of an acrylic base with retention elements such as Adams' clasps, C clasps, or vestibular archesPatients in the removable space maintainer group were instructed to use their appliances during the day, except while eating and sleeping, and to clean them by brushing after toothbrushing.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I: Fixed Space Maintainer with Manual Toothbrush | Other | Device: Manual toothbrushIn this group, patients with fixed space maintainers used manual toothbrushes (Oral-B Cavity Defense; Procter \& Gamble, USA) during study period. |
| Group II: Fixed Space Maintainer with Electric Toothbrush | Experimental | Device: Electric toothbrushIn this group, patients with fixed space maintainers used electric toothbrushes (Oral-B Vitality Cross Action; Procter \& Gamble, USA) during study period. |
| Group III: Removable Space Maintainer with Manual Toothbrush | Other | Device: Manual toothbrushIn this group, patients with removable space maintainers used manual toothbrushes (Oral-B Cavity Defense; Procter \& Gamble, USA) during study period. |
| Group IV: Removable Space Maintainer with Electric Toothbrush | Experimental | Device: Electric toothbrushIn this group, patients with removable space maintainers used electric toothbrushes (Oral-B Vitality Cross Action; Procter \& Gamble, USA) during study period. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 6-12 years who required a space maintainer due to premature loss of primary molar teeth were included if they were medically healthy; had no periodontal disease, temporomandibular disorders, bruxism, abnormal oral habits, or physical/mental disabilities affecting hand movement; were not on regular medication; had not used antibiotics within the past three months or plaque-preventive agents within the last six months; and were able to comply with scheduled follow-up visits.
Key exclusion criteria (1 listed)
- Patients who failed to attend follow-up appointments or developed an infection/disease requiring antibiotic therapy during the study were excluded.
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 |
|---|---|---|
| Electric toothbrushTwo minutes; twice a day; 3-months. | Device | Group II: Fixed Space Maintainer with Electric Toothbrush, Group IV: Removable Space Maintainer with Electric Toothbrush |
| Manual toothbrushTwo minutes; twice a day; 3-months. | Device | Group I: Fixed Space Maintainer with Manual Toothbrush, Group III: Removable Space Maintainer with Manual Toothbrush |
Primary outcome
Change in Plaque Index (PI)
Time frame: Baseline (T0), 1 month (T1), and 3 months (T2).
Evaluation of plaque index scores using the Modified Silness and Löe Index.
Change in Gingival Index (GI)
Time frame: Baseline (T0), 1 month (T1), and 3 months (T2)
Evaluation of gingival index scores using the Gingival Index.
Change in Bleeding on Probing (BOP)
Time frame: Baseline (T0), 1 month (T1), and 3 months (T2)
Evaluation of bleeding on probing scores using the Bleeding on Probing (bop) Index
Change in Periodontal Pocket Depth (PPD)
Time frame: Baseline (T0), 1 month (T1), and 3 months (T2)
Evaluation of periodontal pocket depth (PPD)
Change in salivary Streptococcus mutans levels
Time frame: Baseline (T0), 1 month (T1), and 3 months (T2)
Change in salivary Lactobacillus levels
Time frame: Baseline (T0), 1 month (T1), and 3 months (T2)
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 29 Sep 2025.
- Individual participant dataSharing planned: No
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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 Electric toothbrush and Manual toothbrush in people with Periodontal Parameters and Oral Microbial Colonization, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 29 Sep 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 Turkey (Türkiye). 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?
Change in Plaque Index (PI) (time frame: Baseline (T0), 1 month (T1), and 3 months (T2).). The study lists 6 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 29 Sep 2025.