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Extraction Socket HealingPhase 4NCT06587880

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

A Phase 4 study testing Chlorhexidine Gluconate, Bone Bioactive Liquid and Hyaluronic Acid mouthwash in people with Extraction Socket Healing and Quality of Life, run by University of Jordan at 1 site in Jordan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Chlorhexidine Gluconate, Bone Bioactive Liquid and Hyaluronic Acid mouthwash
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteJordan
Study dates
10 Aug 2025to Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ahmad Hamdan, Ph.D. in Periodontics contact

+ 962779099199

Ahmad.hamdan@ju.edu.jo

Jordan1 site, 1 recruiting
  • University of Jordan hospital

    Amman, 11941

    Ahmad Hamdan, Ph.D. in Periodontics, + 962779099199, Ahmad.hamdan@ju.edu.jo

    Recruiting

Other trials in Jordan

About this study

Official title: A Randomized Controlled Trial on the Effect of Different Types of Mouthwash on the Healing of Extraction Sockets

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.

Read more

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.
Being tested
Chlorhexidine Gluconate, Bone Bioactive Liquid, Hyaluronic Acid mouthwash, Warm Saline Mouth Rinse
Keywords
Clinical trial, Mouthwash, Socket healing, Postoperative complications, Quality of life
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chlorhexidine GluconateDrug

    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.

  • Bone Bioactive LiquidDrug

    Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.

  • Hyaluronic Acid mouthwashDrug

    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.

  • Warm Saline Mouth RinseDrug

    Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.

Study groups in NCT06587880
Study groupRoleWhat they receive
Bone Bioactive LiquidActive comparatorBone 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.
Receives: Drug: Bone Bioactive Liquid
Chlorhexidine GluconateActive comparatorIt 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.
Receives: Drug: Chlorhexidine Gluconate
Warm Saline Mouth RinseActive comparatorPrescribing 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.
Receives: Drug: Warm Saline Mouth Rinse
Hyaluronic Acid mouthwashActive comparatorIt 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.
Receives: Drug: Hyaluronic Acid mouthwash

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Measured at 3, 7, 14 days, 3 and 6 months postoperatively.

Secondary outcomes (16)
  1. 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).

    Measured: Radiographs will be taken at baseline and at 6 months after extraction.

  2. 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).

    Measured: 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

  3. 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).

    Measured: 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

  4. 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).

    Measured: 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

  5. 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.

    Measured: At 3, 7, 14 days, 3 and 6 months postoperatively.

  6. Pain at the extraction side

    Assessed using a 10cm long visual analog scale (VAS) where 0= no pain and 10= maximum amount of pain.

    Measured: At 3, 7, 14 days, 3 and 6 months postoperatively.

  7. 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.

    Measured: Pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively.

  8. 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.

    Measured: Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively.

  9. Socio-demographic factors and medical history

    Data taken from participants using a form.

    Measured: Once preoperatively.

  10. Peri-operative factors

    Operation time (min) categorized as \<=20, \>20 to 30, \>30 to 40, \>40.

    Measured: During the surgical procedure.

  11. Peri-operative factors

    Amount of anesthesia administered.

    Measured: During the surgical procedure.

  12. Peri-operative factors

    Tooth sectioning (done, not done).

    Measured: During the surgical procedure.

  13. Peri-operative factors

    The surgeon\'s perception of difficulty categorized as \<=9, \>9 to 12, \>12 to 16, \>16.

    Measured: During the surgical procedure.

  14. 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.

    Measured: Once preoperatively.

  15. Pre-operative factors

    Prior symptoms related to the third molar to be extracted categorized as: present, absent.

    Measured: Once preoperatively.

  16. Pre-operative factors

    Indication for the surgical extraction of the third molar categorized as: prophylactic extraction, pain related to the third molar, orthodontic indication.

    Measured: Once preoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start10 Aug 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06587880
Sponsor's protocol ID
224000195
Other IDs
284/2023-2024
Status last verified
May 2026
First submitted
31 Aug 2024
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The plan is to share only IPD used in the results publication

Publications

  • Osunde OD, Adebola RA, Adeoye JB, Bassey GO. Comparative study of the effect of warm saline mouth rinse on complications after dental extractions. Int J Oral Maxillofac Surg. 2014 May;43(5):649-53. doi: 10.1016/j.ijom.2013.09.016. Epub 2013 Dec 5.

    PubMed 24314857
  • Adekunle AA, Egbunah UP, Erinoso OA, Adeyemo WL. Effectiveness of warm saline mouth bath in preventing alveolar osteitis: A systematic review and meta-analysis. J Craniomaxillofac Surg. 2021 Oct;49(10):980-988. doi: 10.1016/j.jcms.2021.09.001. Epub 2021 Sep 4.

    PubMed 34509363
  • Cho H, Lynham AJ, Hsu E. Postoperative interventions to reduce inflammatory complications after third molar surgery: review of the current evidence. Aust Dent J. 2017 Dec;62(4):412-419. doi: 10.1111/adj.12526. Epub 2017 Jun 14.

    PubMed 28498604
  • Maria de Souza G, Elias GM, Pereira de Andrade PF, Andrade Sales KN, Galvao EL, Moreira Falci SG. The Effectiveness of Hyaluronic Acid in Controlling Pain, Edema, and Trismus After Extraction of Third Molars: Systematic Review and Meta-Analysis. J Oral Maxillofac Surg. 2020 Dec;78(12):2154.e1-2154.e12. doi: 10.1016/j.joms.2020.07.005. Epub 2020 Jul 14.

    PubMed 32771444
  • Canellas JVDS, Fraga SRG, Santoro MF, Netto JNS, Tinoco EMB. Intrasocket interventions to prevent alveolar osteitis after mandibular third molar surgery: A systematic review and network meta-analysis. J Craniomaxillofac Surg. 2020 Sep;48(9):902-913. doi: 10.1016/j.jcms.2020.06.012. Epub 2020 Jul 8.

    PubMed 32718882
  • Afat IM, Akdogan ET, Gonul O. Effects of leukocyte- and platelet-rich fibrin alone and combined with hyaluronic acid on early soft tissue healing after surgical extraction of impacted mandibular third molars: A prospective clinical study. J Craniomaxillofac Surg. 2019 Feb;47(2):280-286. doi: 10.1016/j.jcms.2018.11.023. Epub 2018 Dec 3.

    PubMed 30579747
  • Yilmaz N, Demirtas N, Kazancioglu HO, Bayer S, Acar AH, Mihmanli A. The efficacy of hyaluronic acid in postextraction sockets of impacted third molars: A pilot study. Niger J Clin Pract. 2017 Dec;20(12):1626-1631. doi: 10.4103/1119-3077.224131.

    PubMed 29378998
  • Koray M, Ofluoglu D, Onal EA, Ozgul M, Ersev H, Yaltirik M, Tanyeri H. Efficacy of hyaluronic acid spray on swelling, pain, and trismus after surgical extraction of impacted mandibular third molars. Int J Oral Maxillofac Surg. 2014 Nov;43(11):1399-403. doi: 10.1016/j.ijom.2014.05.003. Epub 2014 Jun 10.

    PubMed 24924267
  • Ibraheem W, Jedaiba WH, Alnami AM, Hussain Baiti LA, Ali Manqari SM, Bhati A, Almarghlani A, Assaggaf M. Efficacy of hyaluronic acid gel and spray in healing of extraction wound: a randomized controlled study. Eur Rev Med Pharmacol Sci. 2022 May;26(10):3444-3449. doi: 10.26355/eurrev_202205_28838.

    PubMed 35647824
  • Kim JJ, Song HY, Ben Amara H, Kyung-Rim K, Koo KT. Hyaluronic Acid Improves Bone Formation in Extraction Sockets With Chronic Pathology: A Pilot Study in Dogs. J Periodontol. 2016 Jul;87(7):790-5. doi: 10.1902/jop.2016.150707. Epub 2016 Mar 18.

    PubMed 26991484
  • Gocmen G, Gonul O, Oktay NS, Yarat A, Goker K. The antioxidant and anti-inflammatory efficiency of hyaluronic acid after third molar extraction. J Craniomaxillofac Surg. 2015 Sep;43(7):1033-7. doi: 10.1016/j.jcms.2015.04.022. Epub 2015 May 6.

    PubMed 26027861
  • Rodrigues SV, Acharya AB, Bhadbhade S, Thakur SL. Hyaluronan-containing mouthwash as an adjunctive plaque-control agent. Oral Health Prev Dent. 2010;8(4):389-94.

    PubMed 21180677
  • Romano CL, De Vecchi E, Bortolin M, Morelli I, Drago L. Hyaluronic Acid and Its Composites as a Local Antimicrobial/Antiadhesive Barrier. J Bone Jt Infect. 2017 Jan 1;2(1):63-72. doi: 10.7150/jbji.17705. eCollection 2017.

    PubMed 28529865
  • Phillips C, White RP Jr, Shugars DA, Zhou X. Risk factors associated with prolonged recovery and delayed healing after third molar surgery. J Oral Maxillofac Surg. 2003 Dec;61(12):1436-48. doi: 10.1016/j.joms.2003.08.003.

    PubMed 14663809
  • Sasaki T, Watanabe C. Stimulation of osteoinduction in bone wound healing by high-molecular hyaluronic acid. Bone. 1995 Jan;16(1):9-15. doi: 10.1016/s8756-3282(94)00001-8.

    PubMed 7742090

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Chlorhexidine Gluconate, Bone Bioactive Liquid and Hyaluronic Acid mouthwash in people with Extraction Socket Healing and Quality of Life, run by University of Jordan at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ahmad Hamdan, Ph.D. in Periodontics (+ 962779099199, Ahmad.hamdan@ju.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extraction socket soft tissue healing (time frame: Measured at 3, 7, 14 days, 3 and 6 months postoperatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06587880, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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