Temperature Change of the Pulpal Floor and Restoration With Preheated Resin Composite (A Randomized Clinical Trial)
clinical evaluation of the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
Hypothesis: Could the preheated composite affect the temperature of the pulpal floor
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Minya、エジプト、61519
- Faculty of Dentistry - Minia University
-
-
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:
- Healthy men and women patients of 25-45 years.
- They should have a good oral hygiene level.
- Presence of at least two posterior class I or II carious lesions to be restored with two different composite resin restorations.
- All carious lesions in selected patients didn't close to the pulp in the preoperative radiograph.
- No preoperative pain.
- Normal occlusal contact with opposing teeth.
- No history of periodontal treatment, including periodontal surgery, in the past year.
- All patients had to sign a written consent before being included.
- A good likelihood of recall availability.
Exclusion Criteria:
- patient with severe periodontitis or severe erosion damage.
- patients with a compromised medical history or had received therapeutic irradiation to the head and neck region.
- If analgesics or antibiotics had administered by the patient during the past 12 hours preoperatively as it might alter their pain perception.
- patients reported bruxism or clenching.
- Greater than grade I mobility or pocket depth greater than 5mm.
- Non-restorable teeth or hopeless teeth.
- Immature teeth.
- Radiographic evidence of external or internal root resorption.
- Alcoholic and smoker patients.
- Pregnant or breastfeeding ladies.
- Patients who had physical disabilities, or who are unable to brush their teeth.
- Individuals who had sensitive teeth but with one of the following conditions was excluded from the study, teeth with large restoration, abutment of teeth of removable partial dentures, dental restorations, abutment of teeth of removable partial dentures, enamel cracks, leakage of fillings or other restorations teeth, dental pulp lesions, dental abscesses, pulpitis, and atypical facial pain.
- Patients who had non-carious lesions like attrition, erosion, abrasion or abfraction.
- Patients had participated in a clinical trial within 6 months before commencement of this trial.
- Patients unable to return for a recall appointment.
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:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:Admira 50º C
in this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 50º C
|
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
他の名前:
|
アクティブコンパレータ:Admira 70º C
in this subgroup the patient's teeth was restored with Admira fusion extra resin composite preheated to 70º C
|
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
他の名前:
|
アクティブコンパレータ:Viscalor 50º C
in this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 50º C
|
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
他の名前:
|
アクティブコンパレータ:Viscalor 70º C
in this subgroup the patient's teeth was restored with Viscalor resin composite preheated to 70º C
|
evaluate the effect of preheating BIS-GMA free resin composite at different temperatures on temperature change of the pulpal floor and restorations and compare it with BIS-GMA containing resin composite.
他の名前:
|
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 |
---|---|---|
pulpal floor temperature and restoration temperature
時間枠:one year
|
evaluation the effect of preheating BIS GMA free resin composite at different temperature on temperature change of pulpal floor and restoration and compare it with BIS GMA containing resin composite All readings were taken with the presence of a rubber dam and recorded in Celsius (°C). Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure. (C1): pulpal floor temperature during placement of preheated composite. (C2): top composite surface after packing and before curing. (C3): pulpal floor temperature after curing of the preheated composite. (C4): top composite surface after curing. The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device |
one year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
The effect of different preheating temperatures on restoration temperature and pulpal floor temperature
時間枠:one year
|
Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure.
(C1): pulpal floor temperature during placement of preheated composite.
(C2): top composite surface after packing and before curing.
(C3): pulpal floor temperature after curing of the preheated composite.
(C4): top composite surface after curing.
The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
|
one year
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
The difference in restoration and pulpal floor temperatures before and after curing of preheated resin composite
時間枠:one year
|
Five temperature readings were measured for each tooth; (C0): pulpal floor temperature before beginning the restorative procedure.
(C1): pulpal floor temperature during placement of preheated composite.
(C2): top composite surface after packing and before curing.
(C3): pulpal floor temperature after curing of the preheated composite.
(C4): top composite surface after curing.
The pulpal floor and the restoration temperature of each tooth was measured by a K-type temperature Probe attached to portable mini type thermometer device
|
one year
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Mona I Riad, Professor、Professor at Faculty of Dentistry Cairo University
- スタディディレクター:Nermin A Mahmoud, Lecturer、Lecturer at Faculty of Dentistry Minia University
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- 490
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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
米国FDA規制機器製品の研究
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。
preheating of resin compositeの臨床試験
-
Rawda Hesham Abd ElAziz募集