The Effect of Different Types of Mouthwash on Extraction Sockets' Healing

University of Jordan

Status and phase: Not yet enrolling; Phase 4

Conditions: Postoperative Complications; Extraction Socket Healing; Quality of Life

Treatments: Drug: Hyaluronic Acid mouthwash; Drug: Warm Saline Mouth Rinse; Drug: Bone Bioactive Liquid; Drug: Chlorhexidine Gluconate

Study type: Interventional

Funder types: Other

Identifiers

NCT06587880

284/2023-2024 (Other Grant/Funding Number)

224000195

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

100 participants in 4 patient groups

Bone Bioactive Liquid

Active Comparator group

Description:

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.

Treatment:

Drug: Bone Bioactive Liquid

Chlorhexidine Gluconate

Active Comparator group

Description:

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.

Treatment:

Drug: Chlorhexidine Gluconate

Warm Saline Mouth Rinse

Active Comparator group

Description:

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.

Treatment:

Drug: Warm Saline Mouth Rinse

Hyaluronic Acid mouthwash

Active Comparator group

Description:

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.

Treatment:

Drug: Hyaluronic Acid mouthwash