A Phase 4 interventional study of Chlorhexidine Gluconate and Bone Bioactive Liquid in Extraction Socket Healing, Quality of Life and Postoperative Complications, sponsored by University of Jordan. Recruiting at 1 site in Jordan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by University of Jordan · Phase 4, Interventional, and Supportive care
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:
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's planned enrollment of 100 is below the median of 114 across 766 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →University of Jordan is the lead sponsor of 131 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Bone Bioactive Liquid
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.
Drug: Chlorhexidine Gluconate
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.
Drug: Warm Saline Mouth Rinse
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.
Drug: Hyaluronic Acid mouthwash
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.
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.
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.
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 months
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 months
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 months
Quality of life of the patients (QOL) after extraction
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.
Time frame: At 3, 7, 14 days, 3 and 6 months postoperatively.
Pain at the extraction side
Assessed using a 10cm long visual analog scale (VAS) where 0= no pain and 10= maximum amount of pain.
Time frame: At 3, 7, 14 days, 3 and 6 months postoperatively.
Trismus
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.
Time frame: Pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
Facial swelling at the extraction side
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.
Time frame: Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
Socio-demographic factors and medical history
Data taken from participants using a form.
Time frame: Once preoperatively.
Peri-operative factors
Operation time (min) categorized as \<=20, \>20 to 30, \>30 to 40, \>40.
Time frame: During the surgical procedure.
Peri-operative factors
Amount of anesthesia administered.
Time frame: During the surgical procedure.
Peri-operative factors
Tooth sectioning (done, not done).
Time frame: During the surgical procedure.
Peri-operative factors
The surgeon\'s perception of difficulty categorized as \<=9, \>9 to 12, \>12 to 16, \>16.
Time frame: During the surgical procedure.
Pre-operative factors
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.
Time frame: Once preoperatively.
Pre-operative factors
Prior symptoms related to the third molar to be extracted categorized as: present, absent.
Time frame: Once preoperatively.
Pre-operative factors
Indication for the surgical extraction of the third molar categorized as: prophylactic extraction, pain related to the third molar, orthodontic indication.
Time frame: Once preoperatively.
Plan to share: Yes — The plan is to share only IPD used in the results publication
Supporting information: Study protocol
Time frame: Beginning from publication with no end date
Access criteria: The principal investigator will review requests for IPD sharing according to the predetermined set of criteria. The criteria that must be met in order for data to be shared are: having a study protocol that has been approved by an independent review committee identified for IPD meta-analyses. The study protocol must be submitted through email then when reviewed data requestors will need to sign a data access agreement. The data requestor will be provided with the IPD file that can be accessed by them only by having their email listed as a viewer in the sharing list of a folder stored on the DropBox website, this folder has the data excel sheet file and the study protocol as the supporting material.
Data sharing details ↗ · www.dropbox.com
Started Aug 2025 (actual). Primary completion is estimated for Dec 2026, 16 months after the start.
Of 45 non-industry phase 4 interventional studies under Postoperative Complications, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 32. This study's planned 16 months is below that.
Counting every sponsor, half of 46 studies reached it within 25 months; a quarter within 19 and three quarters within 32.
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Studies of the drugs tested here: Chlorhexidine gluconate · Hyaluronic Acid