Clinical & Radiographic Efficacy Using LLLT & CRYO on M.P.M Pulpotomy

NCT06711081 | Recruiting

• 1 other identifier: LLLT& CRYO pulpotomy on M.P.M
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This in-vivo study aims to evaluate the efficacy of the low level laser therapy and cryotherapy in treatment of vital pulpotomy in mature permanent molar evaluating the post operative pain and the radiographic changes in pulpal and periodontal regions.

Conditions

MTA Vital Tooth Pulpotomy

Keywords

vital pulp therapy permanent teeth pulpotomy LLLT

Outcome Measures

Primary Outcomes (1)

• radiographic changes

  and x-ray change either pulpal or periapical using CBCT subtraction

  one year after treatment

Secondary Outcomes (1)

• Post operative pain

  one week after treatment

Study Arms (3)

• Group I: Conventional complete Pulpotomy using MTA (control group).

NO INTERVENTION

MTA putty material will be placed using premixed capsule which will be triturated according to manufacturer's instructions. MTA will be placed in a 2-3 mm layer above the pulp tissue using an amalgam carrier and gently packed to the canal orifice using a condenser, then it will be covered by moistened cotton pellet for 2 minutes to achieve the initial setting, then the cotton pellet will be removed. A layer of resin modified glass ionomer cement will be placed and the tooth will be restored using light cured composite filling material .

• Group II: LLLT following complete pulpotomy.

ACTIVE COMPARATOR

after achieving homeostasis, LLLT will be applied using diode laser of 810 nm wave length with energy of 2 J/cm2 under a continuous mode with power output of 100 mW for about 10 sec with laser tip size 600 μm and 2 mm away from the canal orifice, Then MTA will be placed and the tooth will be restored as in group I.

Device: low level laser device cryotherapy

• Group III: Cryotherapy following complete pulpotomy.

ACTIVE COMPARATOR

after achievement of homeostasis, the cryotherapy will be applied using small piece of shaved sterile ice wrapped with sterile piece of gauze (0° Celsius) which will be placed over the pulpal tissue in the pulp chamber. After approximately 60 seconds, the molten ice will be removed, then MTA will be placed and the tooth will be restored as in group I.

Device: low level laser device cryotherapy

Interventions

low level laser device cryotherapy DEVICE

using new device direct on the pulp tissue

Also known as: cryotherapy

• Group II: LLLT following complete pulpotomy.; • Group III: Cryotherapy following complete pulpotomy.

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Restorable vital and mature mandibular molar teeth with irreversible pulpitis.
• Teeth with deep caries or large restoration.
• Pre-operative radiograph showing normal periapical structure.
• Teeth with normal periodontal status .

You may not qualify if:

• Medically compromised patients with active systemic disease as uncontrolled diabetes mellitus, hypertension or cardiac diseases.
• Teeth with periapical lesion.
• Sinus tract or swelling.
• Moderate or severe marginal periodontitis.
• Patient allergic to any material or medication used in this study.
• Teeth with moderate to severe mobility.
• Teeth with periodontal diseases.
• Teeth with anatomical variations.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry

Tanta, Egypt

RECRUITING

Related Publications (2)

• Murray PE. Review of guidance for the selection of regenerative endodontics, apexogenesis, apexification, pulpotomy, and other endodontic treatments for immature permanent teeth. Int Endod J. 2023 Mar;56 Suppl 2:188-199. doi: 10.1111/iej.13809. Epub 2022 Aug 15.

  PMID: 35929348 BACKGROUND

• Duncan HF, El-Karim I, Dummer PMH, Whitworth J, Nagendrababu V. Factors that influence the outcome of pulpotomy in permanent teeth. Int Endod J. 2023 Mar;56 Suppl 2:62-81. doi: 10.1111/iej.13866. Epub 2022 Nov 22.

  PMID: 36334098 BACKGROUND

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• abeer darrag, phd

  Professor of Endodontics

  PRINCIPAL INVESTIGATOR

• tokka moukhatar

  Lecturer of Endodontics

  STUDY DIRECTOR

Central Study Contacts

mohamed motiea, bachelor

CONTACT

01002249832; Mohamed7942staff@dent.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: Assignment

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 2, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: November 1, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)