Extraction Socket Healing, Postoperative Complications, Quality of Life
Conditions
Keywords
Clinical trial, Mouthwash, Socket healing, Postoperative complications, Quality of life
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.
Interventions
DRUGChlorhexidine Gluconate
Prescribed 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.
Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.
Prescribed 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.
Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.
Sponsors
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The study coordinator will carry out the randomization as mentioned to have a list for the order in which interventions will be given, the same coordinator will prepare opaque bags, then they will move mouthwashes into new opaque bottles and put them in the bags at the same order in the randomization list, instructions sheets will be provided also for the specific mouthwash in the bag. The research assistant will have the bags without knowing what is inside them, they will give them to the surgeon after finishing the extraction procedure according to the assigned numbers of the patients which is determined according to the order of visits, the research assistant will leave the surgery room then the surgeon will open the bag to see the instructions to deliver them verbally to the patient and make sure they understand them fully then putting them back in the bag and giving it to the participant.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| 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. | Operation time (min) categorized as \<=20, \>20 to 30, \>30 to 40, \>40. |
| Pre-operative factors | Once preoperatively. | The radiographic anatomical relationship between the tooth roots and mandibular canal as it appears on the radiographic image taken preoperatively, categorized as: No association between root structure and the superior border of the canal, Root structure impinging the superior border of canal, Overlapping root structure and canal. |
Countries
Jordan
Contacts
CONTACTAhmad Hamdan, Ph.D. in Periodontics
PRINCIPAL_INVESTIGATORAhmad Hamdan, Ph.D. in Periodontics
Faculty of Dentistry - University of Jordan
Outcome results
None listed