A Phase 2 interventional study of Tooth extraction and Chlorhexidine mouth wash in Dry Socket, sponsored by Riyadh Colleges of Dentistry and Pharmacy. Status unknown at 1 site in Saudi Arabia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-14.
Sponsored by Riyadh Colleges of Dentistry and Pharmacy · Phase 2, Interventional, and Prevention
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.
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.
Follow up:
The patients will be followed in the third postoperative day. Re-evaluation includes tenderness with probing the socket, empty socket, and assessment of pain by (VAS) from (0, 1, 2,....10). Score 0 representing no pain, 10 representing severe pain. Re-evaluation will be repeated in the seventh post-operative day including the same evaluation points of the third 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.
Frequencies and percentages are calculated for qualitative data (SPSS software version.22). Chi-square test will be applied to compare both subgroups.
46 studies on the registry are indexed under Dry Socket; 10 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 41 interventional studies indexed under Dry Socket.
Browse Dry Socket studies →Riyadh Colleges of Dentistry and Pharmacy is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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Exclusion criteria:
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Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
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Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tooth extraction. The patients will start using Chlorhexidine mouthwash on 2nd day of extraction twice daily for 7 days.
Procedure: Tooth extraction · Drug: Chlorhexidine mouth wash
intra-alveolar application of Manuka Honey after tooth extraction.
Procedure: Tooth extraction · Drug: Intra-alveolar application of Manuka Honey
Tooth removal
Chlorhexidine mouth wash
Also known as: Oraxine 0.2% Chlorhexidine mouth wash
Intra-alveolar application of Manuka Honey directly after extraction.
Also known as: Marks & Spencer Manuka Honey
Pain day 3
Assessment of pain by (VAS) from (0, 1, 2,....10).
Time frame: on the 3rd day
Empty socket day 3
By inspection. The socket is empty and does not contain blood clot
Time frame: on the 3rd day
Empty socket day 7
By inspection. The socket is empty and does not contain blood clot
Time frame: in the 7th day
Tenderness within the socket day 3
By probing the socket
Time frame: on the 3rd day
Tenderness within the socket day 7
By probing the socket
Time frame: on the 7th day
Pain day 7
Assessment of pain by (VAS) from (0, 1, 2,....10).
Time frame: on the 7th day
Plan to share: No
The record gives a start of Oct 2016, a primary completion of Jun 2017 and a completion of Aug 2017. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Chlorhexidine
Riyadh Colleges of Dentistry and Pharmacy