The Effect of Different Types of Mouthwash on Extraction Sockets' Healing
- Conditions
- Extraction Socket HealingQuality of LifePostoperative Complications
- Interventions
- Drug: Bone Bioactive LiquidDrug: Warm Saline Mouth RinseDrug: Hyaluronic Acid mouthwash
- Registration Number
- NCT06587880
- Lead Sponsor
- University of Jordan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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).
- Patients who have taken systemic antibiotics less than 3 months prior to baseline.
- Presence of uncontrolled diabetes, severe nutritional deficiencies and endocrine disturbances.
- Presence of immune deficiency or any immune disease.
- Intravenous bisphosphonates or Oral bisphosphonate intake for more than 3 years.
- Smokers and alcoholics.
- Pregnant or lactating females.
- Hypersensitivity to one of the ingredients listed in any of the mouthwashes, especially chlorhexidine as reactions to this has been reported in the literature.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bone Bioactive Liquid Bone Bioactive Liquid Bone bioactive liquid (BBL) is a saline solution used as a mouthwash that contains calcium chloride (CaCl2) and magnesium dichloride hexahydrate (MgCl2-6H2O) with a net negative charge. Chlorhexidine Gluconate Chlorhexidine Gluconate It is a strong bisbiguanide base, with cationic structure at physiological pH (positively charged), and has a broad-spectrum antibacterial activity that works against Gram-positive and Gram- negative bacteria and certain mycetes. Warm Saline Mouth Rinse Warm Saline Mouth Rinse Prescribing WSMR as a prophylactic postoperatively is due to the fact that the heat of the solution results in a therapeutic increase in blood flow to the extraction socket. Hyaluronic Acid mouthwash Hyaluronic Acid mouthwash It is a high molecular weight non-sulphated polysaccharide. It is biocompatible, non-immunogenic, biodegradable, viscoelastic that make it a preferable biomaterial for medical and pharmaceutical applications without adverse events.
- Primary Outcome Measures
Name Time Method Extraction socket soft tissue healing Measured at 3, 7, 14 days, 3 and 6 months postoperatively. 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.
- Secondary Outcome Measures
Name Time Method Extraction socket Bone healing Radiographs will be taken at baseline and at 6 months after extraction. 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).
The resulting periodontal defect of the adjacent second molar Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months 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).
Quality of life of the patients (QOL) after extraction At 3, 7, 14 days, 3 and 6 months postoperatively. Assessed based on a questionnaire that addresses different aspects including social and work isolation, ability to eat and speak, impairment of sleep schedule, their physical appearance related to swelling, bleeding and Paresthesia. Answers to the presented questions are in the form of a four-point scale regarding their experience at the time the participants given the form to fill.
Pain at the extraction side At 3, 7, 14 days, 3 and 6 months postoperatively. Assessed using a 10cm long visual analog scale (VAS) where 0= no pain and 10= maximum amount of pain.
Trismus Pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively. By measuring the interincisal distance at the maximum mouth opening pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively, then the difference between pre- and postoperative will be taken.
Facial swelling at the extraction side Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively. Assessed using a soft tape to measure the distance between the lowest point of the tragus and the soft tissue pogonion, the lowest point of the tragus and the lateral corner of the mouth, the lateral corner of the eye and the angle of the mandible. These measurements will be taken preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively. Then the difference between the pre-operative and postoperative values will be divided by the value obtained in the preoperative period and multiplied by 100 to have the final percentage for the post-operative day.
Socio-demographic factors and medical history Once preoperatively. Data taken from participants using a form.
Peri-operative factors During the surgical procedure. The surgeon\'s perception of difficulty categorized as \<=9, \>9 to 12, \>12 to 16, \>16.
Pre-operative factors Once preoperatively. Indication for the surgical extraction of the third molar categorized as: prophylactic extraction, pain related to the third molar, orthodontic indication.
Trial Locations
- Locations (1)
University of Jordan hospital
🇯🇴Amman, Jordan