Diabetes and Periodontal Therapy Trial (DPTT)
A Multicenter Randomized Single-Masked Clinical Trial Testing the Effect of Non-surgical Periodontal Therapy on Glycosylated Hemoglobin (HbA1c) Levels in Subjects With Type 2 Diabetes and Chronic Periodontitis
The primary aim of the study is to determine if non-surgical periodontal therapy (scaling and root planing and supportive periodontal therapy) is efficacious compared to delayed therapy in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in subjects with type 2 diabetes and untreated, moderate to advanced chronic periodontitis.
The secondary aims of the study are to:
- evaluate whether 6 month (or shorter-term (3 month)) changes in clinical measures of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level) are related to changes in HbA1c and fasting glucose or insulin resistance as measured by the Homeostasis Model Assessment 2 (HOMA2).
- assess the 3 month and 6 month efficacy of periodontal therapy on all of the above study outcomes. If a treatment response is observed for any of the study outcomes at 3 months, then the trial can evaluate whether this response is sustained at 6 months.
調査の概要
状態
詳細な説明
This study is a multicenter, randomized, controlled, single-masked, Phase III trial to determine if non-surgical periodontal therapy (scaling and root planing) is efficacious in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in subjects with type 2 diabetes and untreated, moderate to advanced chronic periodontitis. Six hundred adults with a diagnosis of type 2 diabetes and chronic periodontitis will be randomized at three Clinical Sites; University of Alabama at Birmingham; the University of Minnesota, Minneapolis; and the University of Texas Health Science Center, San Antonio. The Core Laboratory will be located at the University of Minnesota and the Study Chair's Office and Coordinating Center will be located at Stony Brook University, Stony Brook, New York.
Eligible participants will be randomly assigned to receive either initial non-surgical periodontal therapy with chlorhexidine rinse (treatment subjects) or delayed non-surgical periodontal therapy (control subjects). Control subjects will be offered delayed periodontal therapy (scaling and root planing) following the 6 month visit. Participants meeting all other eligibility criteria and needing essential dental care, i.e., for broken, grossly carious or abscessed teeth, may enroll only following completion of necessary dental treatment. Participants in both study arms will receive oral hygiene instruction and healthy lifestyle information (e.g. diet, exercise) at baseline and at the 3 and 6 month visits.
Periodontal data will be recorded by trained and calibrated examiners at baseline and 3 and 6 months following randomization. Fasting blood will collected at baseline and at 3 and 6 months to measure intermediate links in the putative causal chain between periodontitis and glycemic control. The periodontal health of all subjects will be monitored, and any subject who experiences progressive periodontitis during the study will be provided with non-surgical rescue therapy.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Alabama
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Birmingham、Alabama、アメリカ、35294
- Clinical Site: University of Alabama at Birmingham
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- Clinical Site: University of Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- Core Laboratory: University of Minnesota
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New York
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Stony Brook、New York、アメリカ、11794-8036
- Coordinating Center: Stony Brook University-
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Stony Brook、New York、アメリカ、11794
- Administrative Center/Study Chair's Office: Stony Brook University
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Stony Brook、New York、アメリカ、11794
- Clinical Site: Stony Brook University
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Texas
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Houston、Texas、アメリカ、77030
- University of Texas, Health Sciences Center at Houston
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San Antonio、Texas、アメリカ、78229
- Clinical Site: University of Texas Health Science Center
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- At least 35 years of age
- Screening HbA1c value ≥ 7% and <9%
- Physician diagnosed type 2 diabetes of more than three months duration
- Currently under the care of a physician for diabetes management
- No change in diabetes-related medications during the three months prior to enrollment. Change is defined as any of the following: change in dose of any 1 hyperglycemic drug by more than two-fold, change in dose of insulin of more than 10%, addition or subtraction of an oral hyperglycemic agent or insulin.
- Consent to contact treating physician and obtain physician agreement to refrain from changing diabetes- related medications during DPTT participation unless overt symptoms develop (e.g. polydipsia, polyuria), HbA1c is 9.5% or higher
- Moderate to severe chronic periodontitis, defined as loss of clinical attachment and probing depth of ≥5 mm at two sites in the mouth in 2 or more quadrants
- No definitive periodontal treatment during the six months prior to enrollment
- Likely to have at least 16 natural teeth for the entire length of study
- Informed consent obtained and signed
- Ability and willingness to cooperate with the study protocol and attend all study visits over the next 9 months
- Willingness to avoid pregnancy during study participation
Exclusion Criteria:
- Self-reported serious concurrent disease that at the discretion of the referring physician limits life expectancy to less than 1 year.
- Emergency room visit or physician visit within the last 30 days because of hyperglycemia or diabetes complications.
- Chronic or continuous use (daily for more than 7 consecutive days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months, other than low dose aspirin (e.g. 75-325 mg/day).
- Receiving chronic treatment with systemic corticosteroids, cyclosporine or other systemic immunosuppressive drugs
- Chronic treatment with systemic antibiotics (antibiotics for > 7 consecutive days within 30 days of baseline visit).
- Currently receiving dialysis.
- At increased risk of bleeding complications from dental treatment, based on medical history.
- Requires Essential Dental Care (e.g., treatment for grossly decayed teeth, broken teeth, dental abscesses, peri-apical infections, other dental infections).
- Heavy alcohol consumption (on average > 2 drinks/day for women and > 3 drinks/day for men).
- Currently pregnant or considering becoming pregnant within the 6 month follow-up period
- Any other criteria that in the opinion of the investigator would preclude study completion or problems with compliance
研究計画
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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Non-surgical periodontal therapy
Non-surgical periodontal therapy consisted of scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months
|
Non-surgical periodontal therapy (scaling and root planing)and supportive periodontal therapy with chlorhexidine rinse
|
他の:Delayed non-surgical periodontal therapy
No periodontal treatment for 6 months
|
Delayed non-surgical periodontal therapy (scaling and root planing) after the 6 month visit
|
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 |
時間枠 |
---|---|
Change in Glycosylated Hemoglobin (HbA1c)
時間枠:6 months after randomization
|
6 months after randomization
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Change in glycosylated hemoglobin (HbA1c)
時間枠:3 months after randomization
|
3 months after randomization
|
Change in Fasting Plasma Glucose and Homeostasis Model Assessment 2 (HOMA2)
時間枠:3 and 6 months after randomization
|
3 and 6 months after randomization
|
Change in clinical measures of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level)
時間枠:3 and 6 months after randomization
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3 and 6 months after randomization
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Need for Periodontal Rescue Therapy
時間枠:When required
|
When required
|
Change in diabetes medications
時間枠:3 and 6 months after randomization
|
3 and 6 months after randomization
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Need for Diabetes Rescue Therapy
時間枠:When required
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When required
|
協力者と研究者
スポンサー
協力者
捜査官
- スタディチェア:Steven Engebretson, DMD, MS, MS、Stony Brook University
- スタディディレクター:Leslie Hyman, PhD、Stony Brook University
出版物と役立つリンク
一般刊行物
- Engebretson SP, Hyman LG, Michalowicz BS, Schoenfeld ER, Gelato MC, Hou W, Seaquist ER, Reddy MS, Lewis CE, Oates TW, Tripathy D, Katancik JA, Orlander PR, Paquette DW, Hanson NQ, Tsai MY. The effect of nonsurgical periodontal therapy on hemoglobin A1c levels in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial. JAMA. 2013 Dec 18;310(23):2523-32. doi: 10.1001/jama.2013.282431.
- Geisinger ML, Michalowicz BS, Hou W, Schoenfeld E, Gelato M, Engebretson SP, Reddy MS, Hyman L. Systemic Inflammatory Biomarkers and Their Association With Periodontal and Diabetes-Related Factors in the Diabetes and Periodontal Therapy Trial, A Randomized Controlled Trial. J Periodontol. 2016 Aug;87(8):900-13. doi: 10.1902/jop.2016.150727. Epub 2016 Apr 25.
- DPTT study group; Engebretson S, Gelato M, Hyman L, Michalowicz BS, Schoenfeld E. Design features of the Diabetes and Periodontal Therapy Trial (DPTT): a multicenter randomized single-masked clinical trial testing the effect of nonsurgical periodontal therapy on glycosylated hemoglobin (HbA1c) levels in subjects with type 2 diabetes and chronic periodontitis. Contemp Clin Trials. 2013 Nov;36(2):515-26. doi: 10.1016/j.cct.2013.09.010. Epub 2013 Sep 27.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
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