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Chlorhexidine Versus Normal Saline Socket Irrigation for Prevention of Dry Socket After Lower Wisdom Tooth Extraction (CHX-AO)

Comparison of the Effect of Immediate Post-Extraction Socket Irrigation With Normal Saline Versus Chlorhexidine on the Frequency of Dry Socket: A Single-Blinded Randomized Controlled Trial

Dry socket, also called alveolar osteitis, is a painful complication that can occur after tooth extraction, particularly following removal of impacted lower wisdom teeth. It occurs when the blood clot that normally forms in the extraction socket is lost or breaks down, resulting in pain and delayed healing.

This study will compare two solutions used to irrigate the extraction socket immediately after removal of an impacted lower wisdom tooth: normal saline and chlorhexidine. The study will determine whether immediate socket irrigation with chlorhexidine reduces the frequency of dry socket compared with normal saline.

A total of 174 eligible patients undergoing surgical extraction of impacted lower wisdom teeth will be randomly assigned to receive either normal saline or chlorhexidine for immediate post-extraction socket irrigation. Participants will not be informed which irrigation solution they receive. The extraction will be performed by a single surgeon, and postoperative assessment will be performed by a co-researcher.

Participants will be assessed for signs and symptoms of dry socket on postoperative days 2, 3, and 5. The occurrence of dry socket will be determined using predefined clinical criteria, including pain, trismus, halitosis, gingival inflammation, exposed or bare bone, radiating pain, and ipsilateral lymphadenopathy.

The study will compare the frequency of dry socket between the chlorhexidine and normal saline groups. The findings may help determine whether chlorhexidine is more effective than normal saline for reducing the occurrence of dry socket after surgical extraction of impacted lower wisdom teeth.

Aperçu de l'étude

Description détaillée

Alveolar osteitis, commonly known as dry socket, is a painful postoperative complication that may occur following tooth extraction. It is characterised by moderate to severe pain at the extraction site and may be associated with delayed healing and other local clinical signs. The condition generally develops within the first few days following extraction and may cause considerable discomfort to patients.

The development of alveolar osteitis has been associated with breakdown or loss of the blood clot within the extraction socket. Local fibrinolytic activity and bacterial factors have been proposed as contributing mechanisms. Surgical trauma, bacterial contamination and other patient- and procedure-related factors may increase the risk of alveolar osteitis.

Normal saline is commonly used for irrigation of extraction sockets after surgical tooth removal. Chlorhexidine has antimicrobial and antiseptic properties and has been investigated for its potential role in reducing the occurrence of alveolar osteitis. Previous studies have reported lower frequencies of dry socket following chlorhexidine use compared with saline or other postoperative measures. However, the effectiveness of immediate post-extraction socket irrigation with chlorhexidine compared with normal saline requires further evaluation in the local clinical setting.

This single-blinded randomized controlled trial will compare the effect of immediate post-extraction socket irrigation with chlorhexidine versus normal saline on the frequency of dry socket following surgical extraction of impacted lower wisdom teeth.

Eligible patients will be recruited from the Oral and Maxillofacial Surgery Department, CMH Medical College and Institute of Dentistry, Lahore. Participants will be adults aged 18-50 years who are classified as ASA physical status I or II and who require surgical extraction of impacted lower wisdom teeth with slight to moderate difficulty according to Pederson's scale.

After informed consent is obtained, eligible participants will be randomly allocated to one of two treatment groups using a lottery method. One group will receive immediate irrigation of the extraction socket with chlorhexidine, while the other group will receive immediate irrigation with normal saline. The allocated irrigation solution will be applied after completion of the tooth extraction and before closure of the extraction socket. The extraction procedure will be performed by a single surgeon under local anaesthesia.

Participants will remain unaware of the irrigation solution allocated to them. Postoperative assessment will be performed by a co-researcher to reduce the potential for assessment bias. Standard postoperative instructions and postoperative medications will be provided according to the study protocol.

Participants will be evaluated on postoperative days 2, 3, and 5 for clinical features of alveolar osteitis. Dry socket will be diagnosed when at least three predefined diagnostic criteria are present. The criteria include mild to severe pain, trismus, halitosis, an inflamed or hyperaemic gingival area, exposed or bare bone with an empty socket, radiating pain to the ear or temporal region, and ipsilateral lymphadenopathy.

Trismus will be assessed by measuring the maximum inter-incisal distance in millimetres. A value below 35 mm will be considered indicative of trismus.

The primary purpose of the study is to determine whether immediate post-extraction socket irrigation with chlorhexidine reduces the frequency of alveolar osteitis compared with normal saline. The findings may provide evidence regarding the effectiveness of chlorhexidine as an alternative to normal saline for immediate socket irrigation following surgical extraction of impacted lower wisdom teeth.

Type d'étude

Interventionnel

Inscription (Réel)

174

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Adults aged 18 to 50 years.
  2. Patients requiring surgical extraction of an impacted lower third molar (lower wisdom tooth).
  3. Impacted lower third molars classified as having slight to moderate difficulty according to Pederson's scale.
  4. Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.
  5. Patients of either biological sex.
  6. Patients who provide written informed consent to participate in the study.

Exclusion Criteria:

  1. Systolic blood pressure ≥160 mmHg.
  2. Diastolic blood pressure ≥100 mmHg.
  3. Current smokers.
  4. Alcohol use.
  5. Patients with muscular diseases.
  6. Patients currently taking antibiotics or anti-inflammatory medications.
  7. Patients with physical or mental disabilities that would prevent participation in the study or completion of follow-up assessments.
  8. Patients requiring extraction without bony osteotomy.
  9. Deep or very difficult impactions according to Pederson's scale.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Chlorhexidine Socket Irrigation
Participants allocated to the experimental group will undergo surgical extraction of an impacted lower third molar under local anaesthesia. Immediately after extraction, the extraction socket will be irrigated with chlorhexidine according to the study protocol, followed by socket closure with silk suture. Participants will receive the same postoperative instructions and medications as the comparator group. Postoperative assessment for alveolar osteitis will be performed on days 2, 3, and 5.
Immediate post-extraction irrigation of the surgical extraction socket with chlorhexidine following removal of an impacted lower third molar. The allocated chlorhexidine solution will be applied immediately after extraction and before socket closure with silk suture. The extraction will be performed under local anaesthesia by a single surgeon. The concentration and volume of chlorhexidine will be administered according to the study protocol.
Comparateur actif: Normal Saline Socket Irrigation
Participants allocated to the comparator group will undergo surgical extraction of an impacted lower third molar under local anaesthesia. Immediately after extraction, the extraction socket will be irrigated with normal saline according to the study protocol, followed by socket closure with silk suture. Participants will receive the same postoperative instructions and medications as the experimental group. Postoperative assessment for alveolar osteitis will be performed on days 2, 3, and 5.
Immediate post-extraction irrigation of the surgical extraction socket with normal saline following removal of an impacted lower third molar. The allocated normal saline solution will be applied immediately after extraction and before socket closure with silk suture. The extraction will be performed under local anaesthesia by a single surgeon. The volume of normal saline will be administered according to the study protocol.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Frequency of Alveolar Osteitis (Dry Socket)
Délai: Postoperative days 2, 3, and 5
The frequency of alveolar osteitis (dry socket) will be assessed in participants following surgical extraction of an impacted lower third molar. Alveolar osteitis will be diagnosed when at least three predefined clinical criteria are present, including mild to severe postoperative pain, trismus, halitosis, inflamed or hyperaemic gingiva, exposed or bare bone with an empty socket, radiating pain to the ear or temporal region, and ipsilateral lymphadenopathy. The number and percentage of participants developing alveolar osteitis will be compared between the chlorhexidine and normal saline groups.
Postoperative days 2, 3, and 5

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Postoperative Trismus
Délai: Postoperative days 2, 3, and 5
Trismus will be assessed by measuring the maximum inter-incisal distance in millimetres using a ruler. An inter-incisal distance of less than 35 mm will be considered indicative of trismus. Measurements will be compared between the chlorhexidine and normal saline groups.
Postoperative days 2, 3, and 5
Postoperative Pain Intensity
Délai: Postoperative days 2, 3, and 5
Postoperative pain will be assessed using a Visual Analogue Scale (VAS). VAS is a 10 cm scale, the smaller the VAS Score, the pain is of low intensity and vice versa. Pain intensity will be recorded during postoperative assessment and compared between the chlorhexidine and normal saline groups.
Postoperative days 2, 3, and 5

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chaise d'étude: Asad A Chatha, BDS, FCPS, CMH Lahore Medical College and Institute of Dentistry

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 février 2026

Achèvement primaire (Estimé)

4 octobre 2026

Achèvement de l'étude (Estimé)

28 octobre 2026

Dates d'inscription aux études

Première soumission

5 septembre 2026

Première soumission répondant aux critères de contrôle qualité

5 septembre 2026

Première publication (Réel)

11 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 228/ERC/CMH/LMC

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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