"Comparing the Plaque Removal Ability of Two Different Toothbrushes Among School Going CP Children
2022年9月9日 更新者：Zainab Jahanzeb、Dow University of Health Sciences
"Comparing the Plaque Removal Ability of Triple Head Tooth Brush Versus Single Head Tooth Brush Among School Based Cerebral Palsy Children:A Randomized Control Trial"
It was an intervention utilizing two toothbrushes on school going cerebral palsy children age (6 -18 yrs).
The triple head tooth brush and single head brush was provided to parents along with dental health education to their parent on brushing technique and oral care for their child.
Parents who give consent for their child were enrolled in the study.
The plaque removal ability of toothbrush was assessed by Turesky modified Quigley Hein index.
The reading for plaque score was recorded at base line and after the follow up of 4 weeks.
Difficulties during brushing was also analyzed.
調査の概要
状態
完了
条件
詳細な説明
Study Design :Single blinded Randomized Control Trial
Study Setting: The study was conducted in schools that have cerebral palsy children in Karachi.
Study Duration :From June 2021 to June 2022.
Sampling technique: Non probability purposive sampling technique was used for selection of study population.
Sample Size: Total 58 individuals were recruited in the study. After including the 20% drop out rate 35 subjects were enrolled at each study group which make total sample size of 70 Cerebral Palsy participants. Random allocation was made in two groups in order to keep the sizes of intervention groups similar.
Study Instrument:
- For study intervention two types of tooth brushes were used. The single head and triple head tooth brush.
- For data collection a structured questionnaire was used that collect information on social demographic characteristics, oral hygiene behavior, dentition status, plaque status and difficulties associated with brushing.
Data Collection Method:
- The study used a single-blind, parallel, and randomized controlled trial (RCT) design.
- A total 70 Cerebral palsy children were recruited in the study which was stratified into two groups of 35 children each in intervention and control group.
- Intervention group was given triple head tooth brush with fluoridated toothpaste whereas control group was given single head tooth brush with fluoridated toothpaste.
- Dental health education on oral care was given to participant's parent along with brushing technique demonstrated on model as well on their child's teeth.
- Data was collected through structured questionnaire. Oral health assessment was recorded through DMFT/dmft index. Plaque index was calculated by Turesky modified Quigley Hein index by dyeing the plaque on tooth surface by plaque disclosing tablets. Difficulties during brushing were also evaluated.
- Statistical analysis involved pair sample t test, repeated measure ANOVA, Chi-square and Fisher's exact test.
研究の種類
介入
入学 (実際)
70
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Sindh
-
Karachi、Sindh、パキスタン、75300
- Zainab Khaliq Ansari
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
6年～18年 (子、大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- • Parents who give consent to enrol in study and their children (age: 6-18yrs) who cooperate to allow to perform oral assessment.
Exclusion Criteria:
- • Children unable to cooperate due to underlying systematic condition because of their motor and mental illness.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group 1 Single head toothbrush
Cerebral palsy children were given single head tooth brush along with fluoridated toothpaste for brushing.
|
To compare the plaque removing ability of two different tooth brushes in school going cerebral palsy children.
|
|
実験的：Group 2 Triple head toothbrush
Cerebral palsy children were given triple head tooth brush along with fluoridated toothpaste for brushing.
|
To compare the plaque removing ability of two different tooth brushes in school going cerebral palsy children.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Plaque Index Score
時間枠：Before and after the intervention of four weeks
|
Plaque score was recorded through Turesky modified Quigley Hein Index to observe improvement in plaque score before and after the intervention.
|
Before and after the intervention of four weeks
|
|
Difficulties associated with toothbrushing e.g Bleeding during brushing, gag reflex, enable reaching more teeth and time required for brushing.
時間枠：At postintervention after four weeks.
|
At postintervention after four weeks.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
DMFT/dmft index
時間枠：At Baseline
|
To assess dentition status
|
At Baseline
|
|
Oral Hygiene Behavior e.g. brushing frequency, complain of pain and visit to a dentist during last 12 months
時間枠：At Baseline
|
Brushing frequency, complain of pain and visit to a dentist during last 12 months.
|
At Baseline
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Nadia Shah, M.Sc,Mphil、Dow University of Health Sciences
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年12月18日
一次修了 (実際)
2022年5月11日
研究の完了 (実際)
2022年7月15日
試験登録日
最初に提出
2022年9月5日
QC基準を満たした最初の提出物
2022年9月9日
最初の投稿 (実際)
2022年9月13日
学習記録の更新
投稿された最後の更新 (実際)
2022年9月13日
QC基準を満たした最後の更新が送信されました
2022年9月9日
最終確認日
2022年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- DowUHS clnical trial
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。