Postoperative PainPhase 4TETRAMOLNCT07738861
Effect of Intraoperative Tetracycline on Postoperative Pain After Mandibular Molar Extraction
A Phase 4 study testing Tetracycline and No Intrasocket Medicament in people with Postoperative Pain and Mandibular Molar Extraction, run by CMH Lahore Medical College and Institute of Dentistry at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain, Mandibular Molar Extraction, Tooth Extraction
- What is being tested?
- Tetracycline and No Intrasocket Medicament
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2026to 28 Oct 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intraoperative Tetracycline on Postoperative Pain After Mandibular Molar Extraction: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Tetracycline, No Intrasocket Medicament
- Keywords
- Tetracycline, Intrasocket Tetracycline, Mandibular Molar, Surgical Tooth Extraction, Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetracyclineDrug
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 MedicamentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No Intrasocket Medicament |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours, 48 hours, and 7 days after mandibular molar extraction
Secondary outcomes (1)
Analgesic consumption
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.
Measured: Within 7 days after mandibular molar extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start10 Jan 2026
- Primary completion23 Sep 2026 (estimated)
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMH Lahore Medical College and Institute of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asad A Chatha, BDS, FCPS, Study chair, CMH Lahore Medical College and Institute of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738861
- Sponsor's protocol ID
- 196/ERC/CMH/LMC
- Other IDs
- 196/ERC/CMH/LMC
- Acronym
- TETRAMOL
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No