Clinical trial NCT06587880: The Effect of Different Types of Mouthwash on Extraction Sockets' Healing
Official title: A Randomized Controlled Trial on the Effect of Different Types of Mouthwash on the Healing of Extraction Sockets
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Extraction Socket Healing
Quality of Life
Postoperative Complications
Keywords: Clinical trial
Mouthwash
Socket healing
Postoperative complications
Quality of life
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Extraction socket soft tissue healing
timeFrame: Measured at 3, 7, 14 days, 3 and 6 months postoperatively.
Secondary outcomes:
measure: Extraction socket Bone healing
timeFrame: Radiographs will be taken at baseline and at 6 months after extraction.
measure: The resulting periodontal defect of the adjacent second molar
timeFrame: 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
measure: The resulting periodontal defect of the adjacent second molar
timeFrame: 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
measure: The resulting periodontal defect of the adjacent second molar
timeFrame: 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
measure: Quality of life of the patients (QOL) after extraction
timeFrame: At 3, 7, 14 days, 3 and 6 months postoperatively.
measure: Pain at the extraction side
timeFrame: At 3, 7, 14 days, 3 and 6 months postoperatively.
measure: Trismus
timeFrame: Pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
measure: Facial swelling at the extraction side
timeFrame: Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
measure: Socio-demographic factors and medical history
timeFrame: Once preoperatively.
measure: Peri-operative factors
timeFrame: During the surgical procedure.
measure: Peri-operative factors
timeFrame: During the surgical procedure.
measure: Peri-operative factors
timeFrame: During the surgical procedure.
measure: Peri-operative factors
timeFrame: During the surgical procedure.
measure: Pre-operative factors
timeFrame: Once preoperatively.
measure: Pre-operative factors
timeFrame: Once preoperatively.
measure: Pre-operative factors
timeFrame: Once preoperatively.
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan hospital
Study officials:
affiliation: Faculty of Dentistry - University of Jordan
name: Ahmad Hamdan, Ph.D. in Periodontics
role: PRINCIPAL_INVESTIGATOR
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