Effect of Intraoperative Tetracycline on Postoperative Pain After Mandibular Molar Extraction

NCT07738861 | Completed Phase 4 DMC

• 2 other identifiers: CMH-OMFS-TETRA-2026-01196/ERC/CMH/LMC
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain is a common complication following mandibular molar extraction and can negatively affect patient comfort and recovery. Tetracycline is a broad-spectrum antibiotic with anti-inflammatory properties that may reduce postoperative inflammation and pain when applied locally to the extraction socket. This randomized controlled trial aims to evaluate the effect of intraoperative placement of tetracycline on postoperative pain in patients undergoing surgical extraction of mandibular molars. A total of 74 eligible patients will be randomly assigned to receive either intrasocket tetracycline or no local medicament following tooth extraction. All participants will receive the same standard postoperative care and analgesic regimen. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 24 hours, 48 hours, and 7 days after surgery. The findings of this study will provide evidence regarding the effectiveness of local tetracycline in reducing postoperative pain and may help improve postoperative pain management following mandibular molar extraction.

Conditions

Postoperative Pain; Mandibular Molar Extraction; Tooth Extraction

Keywords

Tetracycline; Intrasocket Tetracycline; Mandibular Molar; Surgical Tooth Extraction; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity

  Postoperative pain will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain scores will be compared between the tetracycline and control groups to evaluate the effectiveness of intraoperative intrasocket tetracycline placement following mandibular molar extraction.

  24 hours, 48 hours, and 7 days after mandibular molar extraction

Secondary Outcomes (1)

• Analgesic consumption

  Within 7 days after mandibular molar extraction

Study Arms (2)

Intrasocket Tetracycline Group

EXPERIMENTAL

Participants assigned to this arm will undergo surgical extraction of a mandibular molar followed by placement of 250 mg tetracycline mixed with 0.5 mL sterile saline directly into the extraction socket before primary wound closure. All participants will receive the same standardized postoperative care, including diclofenac sodium and oral hygiene instructions. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 24 hours, 48 hours, and 7 days.

Drug: Tetracycline

Control Group

OTHER

Participants assigned to this arm will undergo surgical extraction of a mandibular molar without placement of any intrasocket medicament. All participants will receive the same standardized postoperative care, including diclofenac sodium and oral hygiene instructions. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 24 hours, 48 hours, and 7 days.

Other: No Intrasocket Medicament

Interventions

Tetracycline DRUG

Tetracycline (250 mg) mixed with 0.5 mL sterile saline will be placed directly into the extraction socket immediately following surgical extraction of the mandibular molar and before primary wound closure. The intervention is intended to provide localized antimicrobial and anti-inflammatory effects to reduce postoperative pain. All participants will receive identical postoperative analgesics and oral hygiene instructions.

Intrasocket Tetracycline Group

No Intrasocket Medicament OTHER

Participants will undergo the same standardized surgical extraction procedure without placement of any intrasocket medicament. All participants will receive identical postoperative management, including diclofenac sodium, oral hygiene instructions, and follow-up assessments. This intervention serves as the control for comparison with the tetracycline group.

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18 to 60 years. Male and female participants. Patients requiring surgical extraction of a mandibular molar. American Society of Anesthesiologists (ASA) Physical Status I or II. Able and willing to provide written informed consent and comply with study follow-up.

You may not qualify if:

• Pregnant or lactating women. Patients with systemic conditions that contraindicate oral surgery (e.g., uncontrolled diabetes mellitus or immunosuppressive disorders).
• Current use of antibiotics or medications that may interfere with wound healing (e.g., anticoagulants or bisphosphonates).
• Known allergy or hypersensitivity to tetracycline or related antibiotics. Requirement for simultaneous extraction of adjacent teeth. Presence of active oral infection, including pericoronitis, at the surgical site.
• Severely compromised oral hygiene that may affect postoperative healing. Individuals who are unable to cooperate with the study procedures or attend follow-up visits because of physical or cognitive impairment.

Sponsors & Collaborators

• CMH Lahore Medical College and Institute of Dentistry: lead

Study Sites (1)

CMH Lahore

Lahore, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tetracycline

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants and the operating surgeon are aware of treatment allocation because the intervention is applied directly into the extraction socket during surgery. Postoperative pain will be assessed using a standardized Visual Analog Scale (VAS).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: This is a single-center, prospective, parallel-group randomized controlled trial. Eligible participants will be randomly assigned in a 1:1 ratio to receive either intrasocket tetracycline or no intrasocket medicament following mandibular molar extraction. Outcomes will be compared between the two groups at predefined postoperative time points.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: January 10, 2026
• Primary Completion: January 23, 2026
• Study Completion: June 28, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)