Periapical Lesion HealingNCT07237620
The Effect of Different Intracanal Medicaments on Periapical Lesion Healing
A study testing Diclofenac sodium in people with Periapical Lesion Healing and Apical Periodontitis, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
This study is planned to evaluate the effects of two different intracanal medicaments-calcium hydroxide and diclofenac sodium-on periapical healing following endodontic retreatment. Fifty-four patients will be included and randomly assigned into two groups according to the type of medicament used. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Lesion Healing, Apical Periodontitis
- What is being tested?
- Diclofenac sodium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 1 Apr 2027
- Phase
- Interventional
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study is planned to include patients aged 18-60 years who are systemically healthy (ASA I-II), present with apical periodontitis after primary root canal treatment, and have single-rooted, root-filled mandibular teeth with a periapical index (PAI) score of ≥3.
- Endodontic treatment failure is to be evaluated based on clinical and radiographic examinations. The duration of the initial endodontic treatment is to be at least four years or longer and/or the teeth are to exhibit clinical symptoms and signs. Previous root canal fillings are to be assessed for obturation quality and classified as satisfactory if they meet the following criteria: no visible voids, good condensation, and termination within 1-2 mm of the radiographic apex. If one or more of these criteria are not fulfilled, the obturation is to be classified as poor quality.
- The presence of post-treatment apical periodontitis, poor obturation quality, and/or persistent or newly developed symptoms (such as spontaneous pain, tenderness to palpation or percussion) and/or sinus tract formation are to be considered as indications for retreatment.
Who cannot join
- Patients with a history of psychiatric disorders, allergic reactions, or pregnancy, and those who have taken analgesics within seven days prior to treatment or antibiotics within the previous three months, are to be excluded from the study.
- Teeth presenting with a periodontal pocket depth greater than 4 mm, severe coronal destruction preventing rubber dam placement, vertical root fracture, internal or external resorption, ankylosis, overfilling, open apex, or that have undergone surgical or nonsurgical retreatment after primary therapy are to be excluded. Teeth with perforation or fractured instruments are also to be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Merve Sarı
Hatay, Antakya, 31060
Merve Sarı, DDS,MSc, +905546430401, sarimerve94@outlook.com
About this study
Official title: Comparison of Calcium Hydroxide and Diclofenac Sodium as Intracanal Medicaments on Periapical Healing: A Fractal Analysis Study
This study is planned to evaluate the effects of two different intracanal medicaments-calcium hydroxide and diclofenac sodium-on periapical healing following endodontic retreatment. Fifty-four patients will be included and randomly assigned into two groups according to the type of medicament used. All procedures will be performed by a single experienced endodontist under standardized clinical conditions. Periapical lesion healing will be assessed radiographically at baseline and after 12 months using fractal analysis to quantitatively evaluate bone regeneration. The primary outcome will be the change in the fractal dimension values between the initial and follow-up radiographs.
Read the detailed description
Removal of Previous Root Canal Filling All stages of the root canal procedure are to be performed by a single endodontist with seven years of clinical experience. Local anesthesia is to be achieved with supraperiosteal infiltration of 4% articaine containing 1:100,000 epinephrine (Ultracain D-S; Sanofi, Paris, France). The tooth is to be isolated with a rubber dam, and canal access is to be achieved through a conventional access cavity. The filling material in the access cavity is to be removed using a water-cooled diamond fissure bur.
Root filling material is to be removed using ProTaper Universal Retreatment files operated at 500 rpm. D1 (30/0.09), D2 (25/0.08), and D3 (20/0.07) files are to be used in the coronal, middle, and apical thirds, respectively. Apical patency is to be verified, and the master apical file (MAF) is to be used up to the working length, which is to be determined when the electronic apex locator (Morita Root ZX, Tokyo, Japan) displays "0.0" and confirmed radiographically.
The MAF is to be selected according to the canal volume, and canal preparation is to be completed. Retreatment is to be considered complete when no residual filling material is observed radiographically.
Medication Application and Randomization Patients are to be randomly assigned into two groups (Ca(OH)₂ and DCS) using block randomization technique (allocation ratio 1:1) via www.randomizer.org. The intracanal medicaments are to be prepared by an independent clinician not involved in the study. Both the operator and the patient are to be blinded to the type of medicament used. The medicaments will have similar appearance, color, and consistency to maintain blinding.
Group 1: 1 g of CH (Kalsin, Konya, Turkey) is to be mixed with 1 mL of distilled water.
Group 2: 1 g of DCS (Fagron, Rotterdam, Netherlands) is to be mixed with 1 mL of distilled water.
After preparation, the medicaments are to be placed into the canal using a lentulo spiral (Dentsply Sirona, Switzerland) set 2 mm short of the working length. The medicament is to be condensed to the canal orifice with a sterile paper point. The canals are to be sealed with a sterile cotton pellet and Cavit (3M ESPE, Seefeld, Germany).
Patients are to be prescribed 400 mg ibuprofen if needed and provided with a contact number for emergency communication in case of persistent or severe pain.
Removal of Medicaments and Root Canal Filling One week later, under rubber dam isolation, the access cavity is to be reopened. The intracanal medicaments are to be removed mechanically using the MAF and irrigation with a total of 10 mL NaOCl. The final irrigation sequence is to consist of 5 mL saline, 3 mL 17% EDTA (1 minute), 5 mL saline, 5 mL 2.5% NaOCl, and a final rinse with 5 mL saline.
All canals are to be obturated using the lateral condensation technique with Bioserra sealer (Dentsply DeTrey GmbH, Konstanz, Germany). All endodontic procedures are to be performed by a single endodontist.
Follow-up and Outcome Evaluation The primary outcome is to be the reduction in periapical lesion volume, which will be assessed by fractal analysis of periapical radiographs obtained before treatment and at the 12-month follow-up. The images are to be analyzed by two blinded evaluators.
Patients are to be recalled after one year for clinical and radiographic evaluation. Clinical signs and symptoms (tenderness to percussion or palpation, pain, deep periodontal pockets, sinus tract, or swelling) are to be recorded Digital radiographs are to be obtained using the same X-ray holder, and standardized exposure settings to ensure consistent diagnostic quality.
All patients are to be invited for an additional follow-up after an average postoperative period of four years. Restorations are to be evaluated clinically and expected to remain of good quality throughout the observation period.
Fractal Analysis Baseline and one-year follow-up digital periapical radiographs of the teeth are to be obtained using a periapical radiography device equipped with standard size #2 photostimulable phosphor plates.
All analyses are to be performed by an experienced dentomaxillofacial radiologist who will be blinded to the group allocation.
- Conditions
- Periapical Lesion Healing, Apical Periodontitis
- Being tested
- Diclofenac sodium
- Keywords
- Apical Periodontitis, intracanal medicaments, Diclofenac sodium, Calcium hydroxide, Fractal analysis, Endodontic retreatment
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac sodiumProcedure or surgery
Also called Calcium hydroxide
Group 1: 1 g of CH (Kalsin, Konya, Turkey) is to be mixed with 1 mL of distilled water.
Group 2: 1 g of DCS (Fagron, Rotterdam, Netherlands) is to be mixed with 1 mL of distilled water.
After preparation, the medicaments are to be placed into the canal using a size 25 lentulo spiral (Dentsply Sirona, Switzerland) set 2 mm short of the working length.
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac sodium | Experimental | 1 g of DCS (Fagron, Rotterdam, Netherlands) is to be mixed with 1 mL of distilled water.
After preparation, the medicaments are to be placed into the canal using a size 25 lentulo spiral (Dentsply Sirona, Switzerland) set 2 mm short of the working length. The medicament is to be condensed to the canal orifice with a sterile paper point. Receives: Procedure: Diclofenac sodium |
| Calcium hydroxide | Active comparator | 1 g of CH (Kalsin, Konya, Turkey) is to be mixed with 1 mL of distilled water.After preparation, the medicaments are to be placed into the canal using a size 25 lentulo spiral (Dentsply Sirona, Switzerland) set 2 mm short of the working length. The medicament is to be condensed to the canal orifice with a sterile paper point. Receives: Procedure: Diclofenac sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical Lesion Healing
The primary outcome is to be the reduction in periapical lesion volume, which will be assessed by fractal analysis of periapical radiographs obtained before treatment and at the 12-month follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start15 Sep 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Periapical Lesion HealingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a prospective, parallel-group, double-blind, randomized controlled clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Sari, Mustafa Kemal University
- Investigators
- Merve Sarı, DDS,MSc, Principal investigator, Mustafa Kemal University Hatay, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237620
- Sponsor's protocol ID
- 1109202503
- Status last verified
- Oct 2026
- First submitted
- 16 Nov 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD due to confidentiality and privacy considerations.
Publications
Negm MM. Effect of intracanal use of nonsteroidal anti-inflammatory agents on posttreatment endodontic pain. Oral Surg Oral Med Oral Pathol. 1994 May;77(5):507-13. doi: 10.1016/0030-4220(94)90233-x.
PubMed 8028874Zhang S, Qu X, Tang H, Wang Y, Yang H, Yuan W, Yue B. Diclofenac Resensitizes Methicillin-Resistant Staphylococcus aureus to beta-Lactams and Prevents Implant Infections. Adv Sci (Weinh). 2021 May 3;8(13):2100681. doi: 10.1002/advs.202100681. eCollection 2021 Jul.
PubMed 34258168de Freitas RP, Greatti VR, Alcalde MP, Cavenago BC, Vivan RR, Duarte MA, Weckwerth AC, Weckwerth PH. Effect of the Association of Nonsteroidal Anti-inflammatory and Antibiotic Drugs on Antibiofilm Activity and pH of Calcium Hydroxide Pastes. J Endod. 2017 Jan;43(1):131-134. doi: 10.1016/j.joen.2016.09.014. Epub 2016 Dec 6.
PubMed 27939738Adl A, Motamedifar M, Malekzadeh P, Sedigh-Shams M. Disinfection of dentinal tubules with diclofenac sodium and N-Acetylcysteine compared with calcium hydroxide as intracanal medicaments against Enterococcus faecalis. Aust Endod J. 2022 Dec;48(3):386-391. doi: 10.1111/aej.12575. Epub 2021 Oct 7.
PubMed 34617640