Extraction Socket HealingNCT07429812
Assessment of Topical Application of Chitosan 0.2% Chlorhexidine Gel on Wound Healing in Diabetic Patients
A study testing Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tis in people with Extraction Socket Healing, run by Tanta University at 1 site in Saudi Arabia.
Trial summary
Despite efforts to prevent postoperative discomfort, immediate side effects of surgical extraction of lower molars include bleeding at the site of extraction, inflammation, pain, and alveolar osteitis especially in diabetic patients Bexident Post is a topical gel commercialized by ISDIN labs (ISDIN, Spain) that… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Extraction Socket Healing
- What is being tested?
- Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 Oct 2025to 10 Dec 2026
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults with controlled diabetes (HbA1c <7
- Mandibular molar extraction indicated
Who cannot join
- Immunocompromised, allergyto Chitosan/CHX.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Topical Application of Chitosan 0.2% Chlorhexidine Gel on Wound Healing Following Mandibular Trans-alveolar Molar Extraction in Diabetic Patients: A Randomized Controlled Clinical Trial
Despite efforts to prevent postoperative discomfort, immediate side effects of surgical extraction of lower molars include bleeding at the site of extraction, inflammation, pain, and alveolar osteitis especially in diabetic patients Bexident Post is a topical gel commercialized by ISDIN labs (ISDIN, Spain) that contains chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol. it has hemostatic, antimicrobial, wound healing properties and proven antiseptic effect.
Read the detailed description
The aim of this study is to Evaluate whether the Chitosan + 0.2% CHX gel improves healing after extraction in diabetic patients Material and Methods The main inclusion criteria for this prospective, randomized, double-blinded clinical study will be adults with controlled diabetes (HbA1c <7) in need of surgical extraction of mandibular molars.
Equal randomization was achieved for 40 patients with the use of a computer-generated random number list, the patient will be divided into two groups , 20 patients for study group and 20 patients for control group. and signed inform consent will be obtained from every patient included in the study .
Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tissue (envelop flap) and , make bone guttering reduction and tooth sectioning and tooth is removed using dental elevators. Study Group: Socket filled with Chitosan + 0.2% CHX gel.
Control Group: No gel, standard instructions only.
Primary outcome measures :
Early Wound Healing Score (EHS).
- Pain: Visual Analogue Scale (VAS).
- Swelling : Intraoral swelling score (Edema).
Secondary outcome measures:
- Complications (dry socket, infections )
- Conditions
- Extraction Socket Healing
- Being tested
- Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tis
- Keywords
- Wound healing, Chitosan gel, Surgical extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tisProcedure or surgery
Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tissue (envelop flap) and , make bone guttering reduction and tooth sectioning and tooth is removed using dental elevators. Study Group: Socket filled with Chitosan + 0.2% CHX gel.
| Study group | Role | What they receive |
|---|---|---|
| Surgical extraction of the offending tooth will be performed under local anesthesia using inferior a | Other | Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tissue (envelop flap) and , make bone guttering reduction and tooth sectioning and tooth is removed using dental elevators. control group : only instruction no gel will be used Receives: Procedure: Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Wound Healing Score (EHS)
The Early Wound Healing Score (EHS) is a 0-10 point clinical tool designed to objectively assess the quality of periodontal soft tissue healing
Measured: 3 days,1 week, 2 weeks, 1 month
Visual analog scale
0 represent no pain and 10 represenet severe pain
Measured: 3 days,1 week, 2 weeks, 1 month.
Swelling
Intraoral swelling score (Edema)
Measured: 3 days,1 week, 2 weeks, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start12 Oct 2025
- Primary completion10 Feb 2026
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extraction Socket HealingStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Kamal Eid Allam, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429812
- Sponsor's protocol ID
- SCBR-514/2025
- Status last verified
- Sep 2026
- First submitted
- 18 Feb 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Topical Application of Chitosan 0.2% Chlorhexidine Gel on Wound Healing Following Mandibular Trans-alveolar Molar Extraction in Diabetic Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07429812
- Acronym / sponsor ID
- SCBR-514/2025
- Conditions
- Extraction Socket Healing
- Keywords
- Wound healing, Chitosan gel, Surgical extraction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 12 Oct 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite efforts to prevent postoperative discomfort, immediate side effects of surgical extraction of lower molars include bleeding at the site of extraction, inflammation, pain, and alveolar osteitis especially in diabetic patients Bexident Post is a topical gel commercialized by ISDIN labs (ISDIN, Spain) that contains chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol. it has hemostatic, antimicrobial, wound healing properties and proven antiseptic effect.
Detailed description
The aim of this study is to Evaluate whether the Chitosan + 0.2% CHX gel improves healing after extraction in diabetic patients Material and Methods The main inclusion criteria for this prospective, randomized, double-blinded clinical study will be adults with controlled diabetes (HbA1c <7) in need of surgical extraction of mandibular molars.
Equal randomization was achieved for 40 patients with the use of a computer-generated random number list, the patient will be divided into two groups , 20 patients for study group and 20 patients for control group. and signed inform consent will be obtained from every patient included in the study .
Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tissue (envelop flap) and , make bone guttering reduction and tooth sectioning and tooth is removed using dental elevators. Study Group: Socket filled with Chitosan + 0.2% CHX gel.
Control Group: No gel, standard instructions only.
Primary outcome measures :
Early Wound Healing Score (EHS).
- Pain: Visual Analogue Scale (VAS).
- Swelling : Intraoral swelling score (Edema).
Secondary outcome measures:
- Complications (dry socket, infections )
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical extraction of the offending tooth will be performed under local anesthesia using inferior a | Other | Procedure: Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tisSurgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tissue (envelop flap) and , make bone guttering reduction and tooth sectioning and tooth is removed using dental elevators. control group : only instruction no gel will be used |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults with controlled diabetes (HbA1c <7
- Mandibular molar extraction indicated
Key exclusion criteria (1 listed)
- Immunocompromised, allergyto Chitosan/CHX.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tisSurgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tissue (envelop flap) and , make bone guttering reduction and tooth sectioning and tooth is removed using dental elevators. Study Group: Socket filled with Chitosan + 0.2% CHX gel. | Procedure or surgery | Surgical extraction of the offending tooth will be performed under local anesthesia using inferior a |
Primary outcome
Early Wound Healing Score (EHS)
Time frame: 3 days,1 week, 2 weeks, 1 month
The Early Wound Healing Score (EHS) is a 0-10 point clinical tool designed to objectively assess the quality of periodontal soft tissue healing
Visual analog scale
Time frame: 3 days,1 week, 2 weeks, 1 month.
0 represent no pain and 10 represenet severe pain
Swelling
Time frame: 3 days,1 week, 2 weeks, 1 month
Intraoral swelling score (Edema)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical extraction of the offending tooth will be performed under local anesthesia using inferior alveolar nerve block technique with buccal mucosa infiltration, make an incision on the gingival tis in people with Extraction Socket Healing, run by Tanta University at 1 site in Saudi Arabia.
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 2 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 2 Oct 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 Saudi Arabia. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Wound Healing Score (EHS) (time frame: 3 days,1 week, 2 weeks, 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.