## Protocol Section
### Identification Module
**NCT ID:** NCT06436664

**Brief Title:** The Effects of Different Tooth Brushing Explanations in Fixed Orthodontic Treatment

**Official Title:** Evaluation of the Effects of Different Tooth Brushing Explanations on Oral Hygiene in Patients With Fixed Orthodontic Treatment

#### Organization Study ID Info
**ID:** 2024/01-04
#### Organization
**Class:** OTHER
**Full Name:** Yuzuncu Yıl University
### Status Module
#### Completion Date
**Date:** 2024-07-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-03-04

**Type:** ACTUAL

#### Start Date
**Date:** 2024-02-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Yuzuncu Yıl University

#### Responsible Party

**Investigator Affiliation:** Yuzuncu Yıl University

**Investigator Full Name:** Yasemin Tunca

**Investigator Title:** PhD, DDS, Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this study was to investigate the effects of various tooth brushing narration methods on the dental and gingival health of orthodontic patients. In this way, the most effective oral hygiene methods for individuals undergoing orthodontic treatment will be determined.

**Detailed Description:** Since orthodontic appliances cause food retention, intensive oral hygiene is needed to maintain dental health. Ineffective brushing triggers gingival inflammation, leading to increased gingival sulcus depth and potentially caries and enamel white lesions. Antimicrobial agents and fluride products are useful, but cannot replace mechanical removal of plaque, which is still considered the most important oral hygiene tool during orthodontic treatment.

In the literature, it has been reported that motivation to maintain oral hygiene during the orthodontic fixed treatment phase has a very positive effect on periodontal health, while in the same studies, plaque index scores increased over time in control groups that were not given repeated oral hygiene motivation . When cases are not given repeated and regular oral hygiene motivation every session in clinical routine, gingival health may deteriorate, and more invasive measures may have to be taken to correct this situation. This is because poor oral hygiene, if left unchecked, can jeopardise the outcome of orthodontic treatment .

For manual toothbrushing, the modified Bass technique (MBT) is generally recommended to achieve optimum plaque reduction with protection of oral tissues against mechanical irritation . A major problem with this brushing technique is that it consists of a complex sequence of movements. Firstly, the toothbrush must be positioned at a 45° angle to the gingival margin. Secondly, the brush should be moved back and forth in small horizontal jerks. Thirdly, with a vertical movement, the brush should be moved in the occlusal direction, i.e. upwards in the lower jaw and downwards in the upper jaw to remove debris. This sequence of movements requires dexterity and attention to technique.

Brushing techniques or sequences have been developed, including verbal instruction through a brochure, demonstration of the technique through a model or instruction through videos .

### Conditions Module

**Conditions:**

- Orthodontic Treatment

- Dental Plaque Induced Gingival Disease

**Keywords:**

- tooth brushing

- fixed orthodontic treatment

- microbial dental plaque

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In patients undergoing fixed orthodontic treatment, orthodontic plaque index, Turesky modified index and gingival index will be applied to score the current intraoral plaque status and gingival health status at baseline, 1st and 3rd months.These patients will not be given any explanation.

**Intervention Names:**

- Other: Tooth brushing

**Label:** Control group

**Type:** OTHER

#### Arm Group 2

**Description:** In patients undergoing fixed orthodontic treatment, orthodontic plaque index, Turesky modified index and gingival index will be applied to score the current intraoral plaque status and gingival health status at baseline, 1st and 3rd months. In Group 1 will receive a standardized brochure on tooth brushing.

**Intervention Names:**

- Other: Tooth brushing

**Label:** Group 1

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** In patients undergoing fixed orthodontic treatment, orthodontic plaque index, Turesky modified index and gingival index will be applied to score the current intraoral plaque status and gingival health status at baseline, 1st and 3rd months. Patients in the 2nd group will be taught standard tooth brushing on a dental model

**Intervention Names:**

- Other: Tooth brushing

**Label:** Group 2

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** In patients undergoing fixed orthodontic treatment, orthodontic plaque index, Turesky modified index and gingival index will be applied to score the current intraoral plaque status and gingival health status at baseline, 1st and 3rd months. Patients in group 3 will be taught standard tooth brushing through a video

**Intervention Names:**

- Other: Tooth brushing

**Label:** Group 3

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control group

- Group 1

- Group 2

- Group 3

**Description:** Firstly, the toothbrush must be positioned at a 45° angle to the gingival margin. Secondly, the brush should be moved back and forth in small horizontal jerks. Thirdly, with a vertical movement, the brush should be moved in the occlusal direction, i.e. upwards in the lower jaw and downwards in the upper jaw to remove debris.

**Name:** Tooth brushing

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The Turesky modified index, plaque on the buccal and lingual surfaces of all teeth. TMQHI scores were recorded as follows:

0, no dental plaque present,

1. isolated areas of dental plaque,
2. A thin dental plaque tape of ≤1 mm,
3. dental plaque covered up to 1/3 of the tooth surface,
4. dental plaque covered between 1/3 and 2/3 of the tooth surface,
5. dental plaque covers ≥2/3 of the tooth surface.

**Measure:** The Turesky modified index

**Time Frame:** Baseline, 1st month, 3rd month

**Description:** Score 0: No plaque accumulation Score 1: There is plaque accumulation covering one side of the bracket base Score 2: There is plaque accumulation covering two sides of the bracket base Score 3: There is plaque accumulation covering three sides of the bracket base Score 4: There is plaque accumulation covering all four sides of the bracket base. and/or the presence of gingival inflammation

**Measure:** Orthodontic plaque index

**Time Frame:** Baseline, 1st month, 3rd month

#### Secondary Outcomes

**Description:** Score 0: Healthy gingiva, Score 1: Gingival characterised by mild inflammation, mild discolouration, mild oedema, no bleeding on probing, Score 2: Moderate inflammation, gingiva shiny, red and oedematous. There is bleeding on probing, Score 3: Severe inflammation, marked redness and oedema. There is a tendency to spontaneous bleeding.

**Measure:** Gingival Index

**Time Frame:** Baseline, 1st month, 3rd month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* The patient with orthodontic attachments at least 4 months
* with permanent dentition

Exclusion Criteria:

* impacted or atypically erupted teeth
* with prosthetic restorations such as crowns or implants
* open bite
* deep bite
* crowding more than 7 mm or polydiastema cases
* Individuals diagnosed with periodontitis
* ndividuals with cleft lip and palate or other craniofacial anomalies

**Healthy Volunteers:** True

**Maximum Age:** 20 Years

**Minimum Age:** 14 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Van

**Country:** Turkey

**Facility:** Yasemin TUNCA

**Zip:** 65080

#### Overall Officials

**Official 1:**

**Affiliation:** Van Yuzuncu Yil University

**Name:** Yasemin TUNCA, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Van Yuzuncu Yil University

**Name:** Dicle ALTINDAL, DDS

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** Van Yuzuncu Yil University

**Name:** Nihal FAHRZADEH, DDS

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Cozzani M, Ragazzini G, Delucchi A, Mutinelli S, Barreca C, Rinchuse DJ, Servetto R, Piras V. Oral hygiene compliance in orthodontic patients: a randomized controlled study on the effects of a post-treatment communication. Prog Orthod. 2016 Dec;17(1):41. doi: 10.1186/s40510-016-0154-9. Epub 2016 Dec 19.

**PMID:** 27891568

**Citation:** Renton-Harper P, Addy M, Newcombe RG. Video instruction to establish a panel of experts to compare tooth cleaning by 4 electric toothbrushes. J Clin Periodontol. 2001 Oct;28(10):917-22. doi: 10.1034/j.1600-051x.2001.028010917.x.

**PMID:** 11686809

**Citation:** Diamanti-Kipioti A, Gusberti FA, Lang NP. Clinical and microbiological effects of fixed orthodontic appliances. J Clin Periodontol. 1987 Jul;14(6):326-33. doi: 10.1111/j.1600-051x.1987.tb00979.x. Erratum In: J Clin Periodontol 1990 Jan;17(1):66.

**PMID:** 3509967

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003741

- Term: Dental Deposits

- ID: D000014076

- Term: Tooth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6970

- Name: Dental Plaque

- Relevance: HIGH

- As Found: Dental Plaque

- ID: M8994

- Name: Gingival Diseases

- Relevance: HIGH

- As Found: Gingival Diseases

- ID: M6938

- Name: Dental Deposits

- Relevance: LOW

- As Found: Unknown

- ID: M16831

- Name: Tooth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003773

- Term: Dental Plaque

- ID: D000005882

- Term: Gingival Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21989

- Name: Salicylic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
