Postoperative Pain Intensity After Pulpotomy

NCT ID: NCT05424796

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2021-10-11

Brief Summary

Introduction: This study aimed to compare postoperative pain rates following sodium hypochlorite (NaOCl) and KTP laser-assisted pulpotomy treatments in permanent teeth with deep caries, and symptomatic irreversible pulpitis. Methods: Ninety patients complaining of permanent teeth pain due to symptomatic irreversible pulpitis were randomly divided into 3 equal groups. Preoperative pain levels were recorded. After the initial bleeding control was achieved with saline, complete hemostasis was achieved by applying saline (control group), 2.5% NaOCl, or KTP laser according to randomly determined patient groups. Patients were asked to mark their pain level on the visual pain scale at the 6th, 24th, 48th, and 72nd hours, and 7th and 30th days depending on the severity of the pain. The permanent restoration was completed after 7 days. Results: According to the present study, the statistical difference between the groups in terms of preoperative pain and percussion pain levels was insignificant.

There was no significant difference between the groups in terms of demographic data. The postoperative pain level of the KTP laser group was significantly lower at the 6th hour compared to the saline group. There was no significant difference between the groups in terms of postoperative pain level at other time intervals. The greatest pain scores occurred in all groups at 6th hour. Conclusions: KTP laser can be preferred primarily in reducing postoperative pain in pulpotomy treatments. KTP laser or NaOCl assisted pulpotomy can be an effective treatment for pain reduction in permanent teeth with symptomatic irreversible pulpitis.

Conditions

Symptomatic Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: Physiological saline (Control group) (n=30)

In this group, hemostasis was achieved by checking the saline soaked cotton pellet placed over canal orifices and into the pulp chamber at 2-minute intervals.

Group Type: EXPERIMENTAL

Physiological saline

Intervention Type: COMBINATION_PRODUCT

Pulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, hemostasis was achieved by checking the saline soaked cotton pellet.

Group 2: Hemostasis and cavity disinfection with NaOCl (n=30)

In this group, 2.5% NaOCl soaked cotton pellets were placed over canal orifices and into the pulp chamber to achieve complete hemostasis.

Group Type: EXPERIMENTAL

Hemostasis and cavity disinfection with NaOCl

Intervention Type: COMBINATION_PRODUCT

Pulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, 2.5% NaOCl soaked cotton pellets were placed over canal orifices.

Group 3: Hemostasis and cavity disinfection with KTP laser (n=30)

In this group, complete hemostasis and cavity disinfection were achieved using a KTP laser (SMARLITE D, Deka, Calenzano FI, Italy). After initial hemorrhage control, complete hemostasis was achieved by exposure to a KTP laser (532 nm wavelength) in noncontact mode at 1.5 W of power with a pulse mode (Ton 100 ms, Toff 100 ms) for 2 s. The diameter of optical fiber was 300 μm. Laser application was repeated 3 times if required. After bleeding control was achieved, cavity disinfection was performed by laser application with a noncontact circular movement for 5 s using 1 W power and 300 nm tip.

Group Type: EXPERIMENTAL

Hemostasis and cavity disinfection with KTP laser

Intervention Type: DEVICE

Pulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, complete hemostasis and cavity disinfection were achieved using a KTP laser (SMARLITE D, Deka, Calenzano FI, Italy).

Interventions

Physiological saline

Pulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, hemostasis was achieved by checking the saline soaked cotton pellet.

Intervention Type: COMBINATION_PRODUCT

Hemostasis and cavity disinfection with NaOCl

Pulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, 2.5% NaOCl soaked cotton pellets were placed over canal orifices.

Intervention Type: COMBINATION_PRODUCT

Hemostasis and cavity disinfection with KTP laser

Pulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, complete hemostasis and cavity disinfection were achieved using a KTP laser (SMARLITE D, Deka, Calenzano FI, Italy).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The patient should be ≥ 18 years old, a single tooth in every patient
• Must be signs of irreversible pulpitis, such as persistent pain that begins spontaneously and/or is exacerbated by cold. This situation should be repeated with the cold test.
• Irreversible pulpitis diagnosed, with or without symptomatic apical periodontitis
• No systemic disease
• Should give a positive response to electrical and thermal tests
• Must be the opposite tooth.
• The tooth is restorable, probing pocket (3mm) depth, and mobility are within normal limits

Exclusion Criteria

• Presence of allergies
• Using analgesics in the last 12 hours or antibiotics in the last 1 week before the procedure.
• Presence of swelling, palpation pain or sinus tract before treatment, root fracture or crack.
• Failure to control bleeding within 6 minutes,
• Presence of bruxism or open apex.
• Insufficient bleeding after pulp exposure
• Observation of advanced canal calcification
• Presence of internal or external root resorption.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

Muhammed Ayhan

Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Demet Altunbaş, DDS, PhD

Role: STUDY_DIRECTOR

Cumhuriyet University

Locations

Sivas Cumhuriyet University

Sivas, Sivas/Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Ayhan M, Altunbas D. Efficacy of Potassium Titanyl Phosphate Laser and Sodium Hypochlorite on Postoperative Pain Intensity Following Pulpotomy in Teeth with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial. Photobiomodul Photomed Laser Surg. 2023 May;41(5):225-233. doi: 10.1089/photob.2022.0152. Epub 2023 Apr 24.

Reference Type: DERIVED

PMID: 37092958 (View on PubMed)

Other Identifiers

Cumhuriyet-University-M-AYHAN-

Identifier Type: -

Identifier Source: org_study_id