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Enrolling by invitation NCT07429812

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

No phase Interventional Extraction Socket Healing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Extraction Socket Healing. Basic parameters: 20 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

  • 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
    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 outcome measures

  • Early Wound Healing Score (EHS) [Time frame: 3 days,1 week, 2 weeks, 1 month]
  • Visual analog scale [Time frame: 3 days,1 week, 2 weeks, 1 month.]
  • Swelling [Time frame: 3 days,1 week, 2 weeks, 1 month]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Immunocompromised, allergyto Chitosan/CHX.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Saudi Arabia · 1 center
  • Tanta University — Al Kharj

Identifiers

NCT: NCT07429812 · SCBR-514/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗