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Completed

NCT Number: NCT07738861

Effect of Intraoperative Tetracycline on Postoperative Pain After Mandibular Molar Extraction

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CMH Lahore

Lahore, Pakistan

About this study

Surgical extraction of mandibular molars is one of the most frequently performed procedures in oral and maxillofacial surgery and is commonly associated with postoperative pain, inflammation, and delayed patient recovery. The intensity of postoperative pain is influenced by tissue trauma, inflammatory mediator release, and bacterial colonization of the extraction socket. Although systemic analgesics are routinely prescribed to control postoperative pain, their prolonged use may be associated with adverse effects. Therefore, adjunctive local therapies that can reduce postoperative pain while minimizing systemic medication use are of clinical interest.

Tetracycline is a broad-spectrum antibiotic with additional anti-inflammatory properties. Besides inhibiting bacterial protein synthesis, tetracycline suppresses matrix metalloproteinases, reduces inflammatory cytokine activity, and promotes wound healing. Local application of tetracycline directly into the extraction socket may provide sustained antimicrobial and anti-inflammatory effects at the surgical site, thereby reducing postoperative pain without increasing systemic drug exposure.

Previous clinical studies have reported beneficial effects of locally applied tetracycline in reducing postoperative pain and improving socket healing following dental extractions. However, evidence from the local population remains limited. Differences in patient characteristics, surgical techniques, and healthcare settings necessitate evaluation of this intervention within the Pakistani population.

This study is designed as a prospective, parallel-group, randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, CMH Lahore Medical College and Institute of Dentistry, Lahore. Seventy-four patients requiring surgical extraction of mandibular molars will be enrolled after providing written informed consent. Participants will be randomly allocated in a 1:1 ratio to either the intervention group or the control group.

Participants in the intervention group will receive 250 mg tetracycline mixed with 0.5 mL sterile saline and placed directly into the extraction socket before wound closure. Participants in the control group will undergo the same surgical procedure without placement of any intrasocket medicament. All surgical procedures will be performed by the same surgeon using a standardized surgical protocol. Postoperative management, including analgesics and oral hygiene instructions, will be identical for both groups.

The primary outcome is postoperative pain measured using the 10-point Visual Analog Scale (VAS) at 24 hours, 48 hours, and 7 days following surgery. Secondary analyses will compare pain scores between treatment groups over time while accounting for demographic and clinical variables.

The results of this trial will provide evidence regarding the effectiveness of intraoperative local tetracycline application as an adjunctive measure for postoperative pain control following mandibular molar extraction. If effective, this simple, inexpensive intervention may improve patient comfort, facilitate recovery, and potentially reduce reliance on systemic analgesic medications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Postoperative Pain Intensity

    Time frame: 24 hours, 48 hours, and 7 days after mandibular molar extraction

    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.

Secondary outcomes

  1. Analgesic consumption

    Time frame: Within 7 days after mandibular molar extraction

    The total number of rescue analgesic tablets consumed by each participant during the first 7 postoperative days will be recorded and compared between the intervention and control groups as an indirect measure of postoperative pain control.

Sponsors and collaborators

Lead sponsor

CMH Lahore Medical College and Institute of Dentistry

Other

Registry information

Official study title

Effect of Intraoperative Tetracycline on Postoperative Pain After Mandibular Molar Extraction: A Randomized Controlled Trial

Acronym: TETRAMOL

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2026
Registry last updated
Jul 31, 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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