The Effect of Different Types of Mouthwash on Extraction Sockets' Healing
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Jordan
About this trial
The goal of this clinical trial is to assess the effect of four different types of mouthwash on socket healing after surgical extractions in male or female patients aged 18 years and older who have a unilateral impacted mandibular third molar indicated for extraction. The main questions it aims to answer are:
The effect of Bone Bioactive Liquid (BBL) mouthwash, Hyaluronic Acid (HA) mouthwash, the Chlorhexidine digluconate (CHX) mouthwash and Warm Saline Mouth Rinse (WSMR) on socket healing after surgical extractions.
The effect of BBL mouthwash, HA mouthwash, the CHX mouthwash and WSMR on patient related factors and their quality of life.
Recruited Participants will be randomized into four intervention groups:
1. First group will receive BBL mouthwash. 2. The second group will receive CHX mouthwash. 3. The third group will be prescribed HA mouthwash. 4. The fourth group will receive Warm Saline Mouth Rinse.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patients aged 18 years and older who have a unilateral impacted mandibular third molar that is indicated for extraction with bone removal and the presence of an adjacent second molar.
Disqualifiers
Soft tissue impaction that will not need any bone removal.
Presence of any acute oral infection including active Pericoronitis.
Patients who have undergone radiotherapy in the head and neck region, chemotherapy or systemic long-term corticosteroid treatment.
Patients receiving medications known to induce gingival hyperplasia; anticonvulsant (phenytoin), immunosuppressant (cyclosporine A), and various calcium channel blockers (nifedipine, verapamil, diltiazem).
Trial design
Design model
Parallel
Treatments tested in this trial
Chlorhexidine Gluconate
DrugPrescribed for 7 days period 2 times a day starting 24 hours post-extraction, the patient is instructed to pour 10 ml of the mouthwash into a measuring cup, rinse for 1 minute at an alternative time to teeth brushing. Do not eat or drink for 30 min after use.
Bone Bioactive Liquid
DrugPrescribed for 7 days period 2 times a day starting 24 hours post-extraction.
Hyaluronic Acid mouthwash
DrugPrescribed for 7 days period 3-4 times a day starting 24 hours post-extraction, the patient is instructed to pour 20 ml of the mouthwash into a measuring cup and rinse for 1 minute, at an alternative time to teeth brushing. Do not eat or drink for 30 mins after use.
Warm Saline Mouth Rinse
DrugPrescribed for 7 days period 2 times a day starting 24 hours post-extraction.
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Bone Bioactive LiquidActive comparator 1 intervention
Group B: Chlorhexidine GluconateActive comparator 1 intervention
Group C: Warm Saline Mouth RinseActive comparator 1 intervention
Group D: Hyaluronic Acid mouthwashActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Extraction socket soft tissue healing
Using a new socket wound healing scale that is a combination of the gingival healing index of Landry et al. and the wound healing scale used by Cervelli et al. to assess the post-extraction wounds in terms of wound dehiscence, epithelialization, quality of granulation tissue filling the post-extraction socket, and depth between early granulation tissue and wound margin. A blunt periodontal probe with millimetric markers will be used for this assessment to score a number between 0 (best) and 4 (worst) for the healing socket.
Time frame
Measured at 3, 7, 14 days, 3 and 6 months postoperatively.Secondary outcomes
1
Extraction socket Bone healing
Using panoramic radiographs and following the Longitudinal radiographic assessment (LRA) technique categorized as: A. The empty socket is completely radiolucent, and lamina dura is observed clearly around the socket. B. Socket region is hazy and lamina dura is observed around the socket. C. There is a mixed radiolucent-radiopaque appearance inside the socket and lamina dura has been partially disappeared. D. Mature bone is seen inside the socket and lamina dura has disappeared completely (no difference between the socket and normal bone).
Time frame
Radiographs will be taken at baseline and at 6 months after extraction.2
The resulting periodontal defect of the adjacent second molar
Will be evaluated using a UNC 15 perio probe with three clinical parameters: the first is probing depth (PD) measured in mm at three sites of the second molar tooth: Distal (D), disto-buccal (DB), and disto-lingual (DL).
Time frame
Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months3
The resulting periodontal defect of the adjacent second molar
Will be evaluated using a UNC 15 perio probe with three clinical parameters: the second is gingival recession (GR) measured in mm at three sites of the second molar tooth: Distal (D), disto-buccal (DB), and disto-lingual (DL).
Time frame
Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months4
The resulting periodontal defect of the adjacent second molar
Will be evaluated using a UNC 15 perio probe with three clinical parameters: the third is bleeding on probing (BOP) measured as present or not at three sites of the second molar tooth: Distal (D), disto-buccal (DB), and disto-lingual (DL).
Time frame
Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov