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Enrolling by Invitation

NCT Number: NCT07429812

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

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.

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Key information

Conditions

Extraction Socket Healing

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Al Kharj, 16272, Saudi Arabia

About this study

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 )

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Immunocompromised, allergyto Chitosan/CHX.

Treatment and study plan

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

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 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.

Primary outcomes

  1. 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

  2. Visual analog scale

    Time frame: 3 days,1 week, 2 weeks, 1 month.

    0 represent no pain and 10 represenet severe pain

  3. Swelling

    Time frame: 3 days,1 week, 2 weeks, 1 month

    Intraoral swelling score (Edema)

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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