Influence of Occlusal Reduction on Endodontic Postoperative Pain

NCT06977009 | Recruiting

• 1 other identifier: occlusal reduction after RCT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the impact of occlusal reduction on post-operative pain after single-visit root canal treatment in patients with necrotic pulps or previously initiated (accessed).

Conditions

Post Operative Pain Management

Outcome Measures

Primary Outcomes (1)

• impact of occlusal reduction on post-operative pain after single-visit root canal treatment by using the visual analog scale (VAS).

  to assess the impact of occlusal reduction on post-operative pain after single-visit root canal treatment in patients with necrotic pulps or previously initiated (accessed) by using visual analog scale (VAS) at 6, 24, 48 hours, and 1 week following the treatment. The VAS consists of a 10-cm line anchored by two extremes "No pain" and "pain as bad as could be". The patients were asked to choose the mark that represented their level of pain. Pain level was assigned to one of four categorical groups: None (0); Mild (1-3); Moderate (4- 6); Severe (7-10). The scale was explained visually, verbally and numerically to facilitate its use by the participants. This will be done by calling the patients by phone to record the degree of pain at these intervals as explained in the study description.

  from the enrollment of the patient up to 1 week for each patient

Study Arms (2)

occlusal reduction (Intervention group)

ACTIVE COMPARATOR

all occlusal contacts on the functional and non-functional cusps as well as on the marginal ridges will be reduced using a diamond bur.

Procedure: Occlusal Reduction

no occlusal reduction (Control group)

NO INTERVENTION

all occlusal contacts will remain intact.

Interventions

Occlusal Reduction PROCEDURE

patients will be allocated to either undergo occlusal reduction (Intervention group) where all occlusal contacts on the functional and non-functional cusps as well as on the marginal ridges will be reduced using a diamond bur, or not undergo occlusal reduction (Control group) where all occlusal contacts will remain intact. The presence or absence of contact will be confirmed using articulating paper where occlusal surfaces will be dried and articulating paper will be held between the teeth with the mandible guided to the centric position. Intact occlusion will be assessed by examining the marks on the teeth. A high-speed handpiece with copious coolant will be used to remove occlusal contacts (Intervention group) or just moved above the surface of the tooth without contacting the occlusal surface (Control group) to facilitate patient blinding.

occlusal reduction (Intervention group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy subjects (ASA I\&II) between the age of 18 and 70 years
• Patients diagnosed with necrotic pulp or previously initiated (accessed).
• Posterior maxillary or mandibular molar tooth.
• Presence of an opposing tooth (or teeth) with normal occlusal contact with the opposing tooth (or teeth).
• Tooth needs cuspal coverage.

You may not qualify if:

• Pregnant females.
• Patients with significant medical conditions (ASA III \& IV).
• Reported bruxism or clenching.
• Took analgesics\\antibiotics or other drugs that might alter their pain during the last 12 hours preoperatively.
• A history of allergic reactions to any of the medications and/or materials used.
• Patients with a tooth that had no contacts or premature contact, fewer than three teeth on one side of the jaw.
• Greater than grade I mobility or pocket depth greater than 5mm.
• Non-restorable crowns, severely curved root canals, or post-treatment endodontic disease were, also, excluded.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Jordan university hospital

Amman, Amman Governorate, 11185, Jordan

RECRUITING

Related Publications (3)

• Shamszadeh S, Shirvani A, Asgary S. Does occlusal reduction reduce post-endodontic pain? A systematic review and meta-analysis. J Oral Rehabil. 2020 Apr;47(4):528-535. doi: 10.1111/joor.12929. Epub 2020 Jan 16.

  PMID: 31880822 BACKGROUND

• Nguyen-Nhon D, Nagendrababu V, Pulikkotil SJ, Rossi-Fedele G. Effect of occlusal reduction on postendodontic pain: A systematic review and meta-analysis of randomised clinical trials. Aust Endod J. 2020 Aug;46(2):282-294. doi: 10.1111/aej.12380. Epub 2019 Oct 22.

  PMID: 31638301 BACKGROUND

• Parirokh M, Rekabi AR, Ashouri R, Nakhaee N, Abbott PV, Gorjestani H. Effect of occlusal reduction on postoperative pain in teeth with irreversible pulpitis and mild tenderness to percussion. J Endod. 2013 Jan;39(1):1-5. doi: 10.1016/j.joen.2012.08.008. Epub 2012 Sep 29.

  PMID: 23228248 BACKGROUND

Related Links

• Effect of Occlusal Adjustment on Postoperative Pain after Root Canal Treatment: A Randomized Clinical Trial

Study Officials

• Mohammad Hammad, Associate Professor

  University of Jordan

  STUDY DIRECTOR

Central Study Contacts

Abdulrahman Mwaffaq Kahhaleh, Masters student

CONTACT

00962795051676; abd_k97@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters studnet

Model Details: A randomized clinical trial will take place at the postgraduate endodontic clinic department at JU Hospital to assess the effect of occlusal reduction on post-operative pain. Participants will be enrolled from the pool of patients referred to the department of endodontics at JUH for root canal treatment, and the trial will be carried out on those diagnosed with necrotic pulps or previously initiated (accessed) teeth.

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 16, 2025
• Study Start: February 28, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 20, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

JO (1)