Mechanical-chemical Gingival Therapy in Diabetics and/or Obese (MCGTDO)
2014年4月23日 更新者：University of Taubate
Evaluation of Mechanical-chemical Gingival Therapy in Diabetic, Obese or Diabese Subjects: Quantitative and Qualitative Analysis of Local and General Aspects.
Diabetes and obesity affect many people in different countries.
Similarly, millions of people have some type of gum disease such as gingivitis.
The present study was conducted to clarify if systemic conditions such as diabetes and obesity could impair the response to gingivitis treatment.
Subjects with gum disease showing diabetes type II (from 40 to 50 subjects), slight to moderate obesity (from 40 to 50 subjects) or its combination (from 40 to 50 subjects) were selected for the present study.
In addition normal-weight subjects with gum disease (from 40 to 50 subjects) besides a group without gum disease (from 40 to 50 subjects) were selected for comparisons.
After verbal and written explanations about the study, subjects who matched study criteria and who signed the informed consent form underwent full oral examinations in two separate visits.
In the first visit, after a clinical examination to verify the levels of gingival inflammation and the accumulated amounts of dental plaque, the bone height was determined by X-Ray examinations.
Bad breath was also evaluated by a chair-side apparatus.
Additional laboratorial examinations included a) quantification of bacteria that cause gum disease from dental plaque samples, b) quantification of inflammatory products from gingival fluid sampling and c) quantification of produced saliva.
Self-report questionnaires were used to check the impact of oral condition and treatment of gum disease in quality of life and individual daily performance.
These examinations were repeated 3 months after dental treatment.
All subjects received ultrasonic dental prophylaxis for cleaning their teeth.
Based on systemic/oral conditions each group rinsed either an essential-oils containing mouth rinse or a placebo rinse.
First rinse was supervised and the other ones were performed at home twice a day for three months.
Each participant also received a toothbrush, a dental floss and a fluoride toothpaste monthly after oral hygiene instructions.
Adherence to the treatment and occurrence of undesirable side effects were monitored throughout the study.
調査の概要
研究の種類
介入
入学 (実際)
240
段階
- フェーズ 4
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
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SP
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Taubate、SP、ブラジル、12020330
- University of Taubate - Nucleus of periodontal research
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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
18年～45年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- plaque-related gingivitis (with no radiographic evidence of periodontal bone resorption and a bleeding site rate of more than 30%)
- periodontally healthy group (with no radiographic evidence of periodontal bone resorption and a bleeding site rate of less than 30%)
- at least 20 natural teeth
- diabetes group: controlled type II diabetes (with a blood glycated hemoglobin level between 6.5 and 7%) that was diagnosed at least 3 years but no more than 5 years prior to the study
- normal salivary flow
- obesity group: obesity level I - body mass index: 30 to 34.99 kg/m2 or obesity level II - body mass index: 35 to 39.99 kg/m2
- normal weight group: body mass index: 20 to 24.99 kg/m2;
Exclusion Criteria:
- gingival overgrowth
- orthodontic devices
- extended prosthetic fixed devices
- removable partial dentures or overhanging restorations
- systemic diseases or other conditions that could influence the periodontal status (other than diabetes within the diabetic group)
- overweight - BMI 25 to 29.99 kg/m2 and obesity level III or morbid obesity - ≥ 40 kg/m2 (obesity group) - alcohol abuse
- pregnancy or breast-feeding
- history of sensitivity or suspected allergies following the use of oral hygiene products
- the need for antibiotic prophylaxis; antibiotics and/or anti-inflammatory drug use in the six months prior to the beginning of the study
- regular use of chemotherapeutic antiplaque/antigingivitis products
- periodontal treatment performed within six months prior to study initiation
- unwillingness to return for follow-up
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Ultrason Essential oils rinse
Ultrasonic debridement followed by twice daily home use of an essential-oils mouth rinse (20mL, 30 seconds for each rinse) for 3 months
|
Test treatment strategy combined mechanical and chemical procedures.
Mechanical procedures were: a) ultrasonic debridement to remove dental plaque, calculus and teeth staining; b) dental polishing and c) oral hygiene instructions related to brushing and flossing.
Toothbrush, dental floss and fluoride dentifrice were monthly provided.
Within the same visit participants performed at the study center the first supervised rinse.
Other rinses were performed at home unsupervised.
A diary card was used to register times of rinsing.
Participants rinsed twice a day a commercially available non-prescription essential-oils solution (20mL, 30 seconds for each rinse) for 3 months.
This solution is composed of eucalyptol 0.092%, menthol 0.042%, methyl salicylate 0.060%, thymol 0.064%, zinc chloride and sodium fluoride 0.0221%.
他の名前：
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プラセボコンパレーター：Ultrason Placebo rinse
Ultrasonic debridement followed by twice daily home use of a placebo rinse (20mL, 30 seconds for each rinse) for 3 months
|
Comparative treatment strategy combined mechanical and chemical procedures.
Mechanical procedures were: a) ultrasonic debridement to remove dental plaque, calculus and teeth staining; b) dental polishing and c) oral hygiene instructions related to brushing and flossing.
Toothbrush, dental floss and fluoride dentifrice were monthly provided.
Within the same visit participants performed at the study center the first supervised rinse.
Other rinses were performed at home unsupervised.
A diary card was used to register times of rinsing.
Participants rinsed twice a day a placebo solution (20mL, 30 seconds for each rinse) for 3 months.
他の名前：
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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 and gingival indices
時間枠：3 months
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percentage of dental surfaces showing mild (scores 0,1), moderate (scores 2,3) or severe (scores 4,5) amounts of dental plaque or showing gingival bleeding (positive or negative) after gentle probing
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3 months
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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。
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
2012年6月1日
一次修了 (実際)
2013年6月1日
研究の完了 (実際)
2013年9月1日
試験登録日
最初に提出
2014年4月9日
QC基準を満たした最初の提出物
2014年4月23日
最初の投稿 (見積もり)
2014年4月25日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年4月25日
QC基準を満たした最後の更新が送信されました
2014年4月23日
最終確認日
2014年4月1日
詳しくは
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。