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CompletedNCT06067542Updated Oct 19, 2023

Effects of Chlorhexidine Toothpaste on Wound Healing After Impacted Tooth Extraction

An interventional study of Surgery of impacted mandibular wisdom teeth in Tooth Impaction and Tooth Diseases, sponsored by Yuzuncu Yıl University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 31 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-19.

Sponsored by Yuzuncu Yıl University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled Mar 2020, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 31 Years
Sex
All
01

Study summary

In this study, the postoperative clinical and microbiologic effects of chlorhexidine toothpaste and chlorhexidine-free toothpaste with the same content were compared after bilateral mandibular impacted third molar surgery. Similarly positioned fully impacted impacted lower third molars were extracted. Bilateral impacted wisdom teeth of the patients were randomly selected. After the operation, the experimental group received Dentasave 0.2% chlorhexidine toothpaste containing chlorhexidine and the control group received toothpaste with the same content but without chlorhexidine. Teeth were extracted by the same dentist at 14-day intervals. For microbiological analysis, saliva samples were taken before the first tooth extraction, before the second tooth extraction 14 days later and on the 28th day and sent to the microbiology laboratory. Wound healing, edema and trismus in both extractions were evaluated 1 week after tooth extraction. Wound healing was evaluated as good, acceptable and poor. VAS (Visual Analog Scale) was used for pain assessment and recorded 14 days after tooth extraction.

02

Conditions studied

  • Tooth Impaction
  • Tooth Diseases

Keywords

  • chlorhexidine, wisdom teeth, dental surgery
03

In context

Tooth, Impacted

122 studies on the registry are indexed under Tooth, Impacted; 15 are open to participants now.

This study's enrollment of 22 is below the median of 70 across 88 interventional studies indexed under Tooth, Impacted.

Browse Tooth, Impacted studies →

Lead sponsor

Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 31 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Volunteers with bilateral fully impacted mandibular wisdom teeth

Exclusion criteria

Exclusion Criteria:

  • Patients were excluded from the study if they did not understand the clinical procedures of the study,
  • Had allergies or intolerance to any of the substances used in the study,
  • Patients on anticoagulant or psychiatric treatment,
  • Pregnant or breastfeeding,
  • Patients using oral contraceptiveswere,
  • Diabetic,
  • Patients with periodontal disease or active infection
  • Smokers of more than 10 cigarettes per day,
  • Poor oral hygiene
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Study group using chlorhexidine toothpaste after wisdom tooth extraction

    22 patients, 17 females and 5 males, 44 bilateral, similarly positioned fully impacted impacted lower third molars were extracted. Bilateral impacted wisdom teeth of the patients were randomly selected. After the operation, the experimental group received Dentasave 0.2% chlorhexidine toothpaste containing chlorhexidine

    Procedure: Surgery of impacted mandibular wisdom teeth

  • Placebo comparator
    Control group using chlorhexidine-free toothpaste after wisdom tooth extraction

    Bilateral impacted wisdom teeth of the patients were randomly selected. After the operation, the control group was given toothpaste with the same ingredients as the study group but without chlorhexidine.

    Procedure: Surgery of impacted mandibular wisdom teeth

Interventions

  • ProcedureSurgery of impacted mandibular wisdom teeth

    All surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with copious amounts of saline, and the wound edges were carefully sutured with simple 4.0 silk braided non-absorbable sutures.

    Also known as: Surgery of impacted mandibular wisdom teeth (the other side)

06

What researchers measure

Primary outcomes

  1. Mouth opening measurements

    the distance between the incisals of the patient's central teeth at maximal mouth opening.

    Time frame: 0-28 days

  2. Facial edema

    Measurement between facial craniometric points (angulus-tragus, angulus-lateral canthus, angulus-nasal base, angulus-lateral canthus, and angulus-pogonion). The number of participants in the split mouth model was 22. A total of 44 impacted teeth were extracted and edema was measured before and 1 week after each extraction.

    Time frame: 0-28 days

  3. Wound healing

    View of the wound site in the operation area. The REEDA scale was used for the clinical evaluation of the intraoral surgical field. This scale It includes five factors that indicate wound healing: Redness, Edema, Echymosis, Discharge, Approximation. Each of the recovery factors is evaluated by giving scores of 0, 1, 2 and 3 and the sum of the scores obtained as a result of the evaluation of these five categories constitutes the REEDA score. The lowest score is 0 and the highest score is 15.

    Time frame: 0-28 days

  4. Visual Analog Scale

    A numerical rating scale VAS was used for pain analysis (0=no pain, 10=most severe pain). The pain levels at 24 hours, 48 hours and 1 week after the surgical procedure were recorded on the patient follow-up form by all patients who participated in the study by explaining that there was no pain at the "zero" level and the most severe pain known at the "10" level on the pain scale, which was organized as a 10 cm horizontal line on the prepared forms.

    Time frame: 0-28 days

  5. Microbiological analysis

    Prior to extraction, a saliva sample was collected from the patient and placed in a sterile 1.5 ml Eppendorf tube and then stored in a -40 oC freezer. After surgical extraction, the patient was given toothpaste with the same content but without chlorhexidine. After a 14-day recovery period, the saliva sample was collected again without extracting the impacted tooth on the contralateral side, and tooth extraction was performed. After the second extraction, the patient was given Dentasave 0.2% Chlorhex toothpaste. The third saliva sample was collected on day 28 (14 days after the second tooth extraction). Saliva samples were stored in sterile universal containers (Eppendorf tubes) and sent to the microbiology laboratory less than 3 hours after collection on days 0, 14, and 28 of the study.

    Time frame: 0-28 days

07

Study locations

1 site
  • Van Yuzuncu Yil University
    Van, 65080, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2020 to primary completion in Mar 2021, 12 months.

Of 55 non-industry interventional studies with no phase under Tooth, Impacted, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's 12 months is below that.

Counting every sponsor, half of 56 studies reached it within 20 months; a quarter within 8 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2023
First posted
Oct 5, 2023
StartActual
Mar 4, 2020
Primary completionActual
Mar 20, 2021
CompletionActual
Dec 1, 2022
Last update
Oct 19, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06067542
Responsible party
Serap Keskin Tunc (Associate Professor Serap Keskin Tunc, Yuzuncu Yıl University) — Principal investigator
First posted
Oct 5, 2023
Start date
Mar 4, 2020
Primary completion
Mar 20, 2021
Completion
Dec 1, 2022
Last update
Oct 19, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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