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Assessment of Topical Application of Chitosan 0.2% Chlorhexidine Gel on Wound Healing in Diabetic Patients

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07429812
Enrollment
40
Registered
2026-02-24
Start date
2025-10-12
Completion date
2026-09-10
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extraction Socket Healing

Keywords

Wound healing, Chitosan gel, Surgical extraction

Brief 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 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 )

Interventions

PROCEDURESurgical 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

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.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Adults with controlled diabetes (HbA1c \<7 * Mandibular molar extraction indicated

Exclusion criteria

* Immunocompromised, allergyto Chitosan/CHX.

Design outcomes

Primary

MeasureTime frameDescription
Early Wound Healing Score (EHS)3 days,1 week, 2 weeks, 1 monthThe 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 scale3 days,1 week, 2 weeks, 1 month.0 represent no pain and 10 represenet severe pain
Swelling3 days,1 week, 2 weeks, 1 monthIntraoral swelling score (Edema)

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026