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临床试验/NCT02678104
NCT02678104Unknown2 期

The Influence of Intra-alveolar Application of Honey on Healing Following Molar Teeth Extraction: A Randomized Clinical Trial

Riyadh Colleges of Dentistry and Pharmacy1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月最近更新:
适应症
干预措施

试验速览

阶段
2 期
发起方
入组人数
100
试验地点
1
主要终点
Pain day 3

研究概览

简要总结

A prospective randomized parallel trial will be carried out on 100 patients who have extraction of single molar tooth. Teeth extractions will be done under local anesthesia. The patients will be divided randomly into two parallel groups. Group 1: The patients will start using Chlorhexidine mouthwash on the second day of extraction twice daily for 7 days. Group 2: After extraction, Manuka Honey will be applied topically into the extraction socket. Postoperative instructions will be given for all patients in addition to the prescription of ibuprofen 600 mg every 8 hours for 3 days.

Re-evaluation:

Postoperative day 3: tenderness with probing the socket, empty socket, food debris, halitosis and assessment of pain. For group 2, the intra-alveolar application of honey will be repeated. Re-evaluation will be repeated in the seventh post-operative day. Acute alveolar osteitis, (dry socket) is diagnosed if the patient presented between the 2nd and 4th days with pain or tenderness in the socket with probing, empty socket and food debris with or without halitosis.

详细描述

A prospective randomized experimental parallel trial will be carried out on 100 male and female patients who have extraction of single molar tooth. Extractions will be performed by dental interns or dental students under supervision of surgery instructors in the Colleges' Clinics.

The study has been registered in the College's Research Center, with a registration number of FRP/2016/23. It will follow the World Medical Association Declaration of Helsinki, the patients will be informed about the objectives of the study, and informed consent has to be signed. All required information was documented in the questionnaire paper regarding name, age, gender, mobile number, file number, smoking, medical condition, tooth indicated for extraction, pre-operative pain and halitosis.

Teeth extractions will be done under local anesthesia. Simple extractions will be done by elevators and forceps, while root separations will be done using a surgical handpiece and burs with normal saline irrigation.

The patients will be divided randomly into two parallel groups by asking them to choose 1 out of 100 playing cards. These cards, which have images of different shapes, have been mixed. The first shape includes 50 cards and represents the first study group, while the second shape includes 50 cards and represents the second study group.

Both groups will receive a bottle of 0.2 % Chlorhexidine mouthwash. Group 1: The patients will start using Chlorhexidine mouthwash on the second day of extraction twice daily for 7 days. Group 2: After tooth extraction, Manuka Honey will be applied topically by a cotton swab into the extraction socket.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Chlorhexidine mouth wash

Experimental

Tooth extraction. The patients will start using Chlorhexidine mouthwash on 2nd day of extraction twice daily for 7 days.

干预措施: Tooth extraction (Procedure)

Chlorhexidine mouth wash

Experimental

Tooth extraction. The patients will start using Chlorhexidine mouthwash on 2nd day of extraction twice daily for 7 days.

干预措施: Chlorhexidine mouth wash (Drug)

Manuka Honey

Experimental

intra-alveolar application of Manuka Honey after tooth extraction.

干预措施: Tooth extraction (Procedure)

Manuka Honey

Experimental

intra-alveolar application of Manuka Honey after tooth extraction.

干预措施: Intra-alveolar application of Manuka Honey (Drug)

结局指标

主要结局

Pain day 3

时间窗: on the 3rd day

Assessment of pain by (VAS) from (0, 1, 2,....10).

次要结局

  • Tenderness within the socket day 3(on the 3rd day)
  • Tenderness within the socket day 7(on the 7th day)
  • Empty socket day 3(on the 3rd day)
  • Pain day 7(on the 7th day)
  • Empty socket day 7(in the 7th day)

研究者

发起方
Riyadh Colleges of Dentistry and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nedal Abu-Mostafa

Dr.

Riyadh Colleges of Dentistry and Pharmacy

研究点 (1)

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