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Necrotic PulpNCT06934317

Maximum Occlusal Bite Force of Necrotic Permanent Teeth Treated by Regenerative Technique: Randomized Clinical Trial

A study testing measurement of maximum bite force using bite fork, conventional root canal treatment and pulp revascularization by induced bleeding in people with Necrotic Pulp and Regenerative Endodontic Procedures, run by Lama Awawdeh at 1 site in Jordan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Further investigation is warranted to ascertain whether the regaining of sensibility and nerve function in regenerated teeth leads to the re-establishment of the proprioceptive protective mechanism inherent in vital teeth. Read more about this study

Who is it for?
Ages 10 to 60 years
What is being tested?
measurement of maximum bite force using bite fork, conventional root canal treatment and pulp revascularization by induced bleeding
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteJordan
Study dates
20 Dec 2024to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 10 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Healthy (ASA Grade 1 \& 2 status). Compliant patient/parent. Mature and immature teeth diagnosed with necrotic pulp. Pulp space is not needed for post and core restoration for cases treated by revascularization.
  • Patients are not allergic to the medications necessary to complete the procedure.
  • The presence of opposing teeth for the included necrotic teeth. No medication (steroids) at the time of investigation, and the patient should not have taken analgesics 6 hours ago.

Who cannot join

  • Medically compromised patient. Patient with generalized chronic periodontitis. Patient with TMD. Current orthodontic treatment. Teeth with sensitivity to percussion. Teeth with previous root canal treatment. Periodontal pocket more than 3mm. Teeth with vertical fractures. Teeth with large restorations, either direct or indirect restoration Teeth with large carious lesions. Non-restorable teeth.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jordan1 site
  • Postgraduate Dental Clinic Jordan University of Science and Technology

    Irbid, POBOX 3030

Other trials in Jordan

About this study

Official title: Maximum Occlusal Bite Force of Necrotic Mature and Immature Permanent Teeth pre-and Post-treatment With the Available Treatment Modalities: Randomized Clinical Trial

Further investigation is warranted to ascertain whether the regaining of sensibility and nerve function in regenerated teeth leads to the re-establishment of the proprioceptive protective mechanism inherent in vital teeth.

Hence, the primary objective of this prospective randomized clinical trial is to conduct a comparative analysis of the potential effects of pulp revascularization in comparison to conventional endodontic treatments, either RCT or apexification on the Maximum occlusal bite force (MBF) in both immature and mature necrotic permanent teeth.

Methods: Upon satisfying the predetermined criteria for inclusion, a total of 184 patients will be recruited for this prospective clinical trial. The study will consist of two groups, specifically Group I: Mature teeth and Group II: Immature teeth, with a sample size of 92 participants in each group. The participants will be assigned randomly to one of the two treatment modalities per group. Group I: will undergo treatment with RCT/revascularization, while Group II will receive MTA plug/revascularization encompassing both mature (n=92) and immature teeth (n=92). MBF will be measured on the selected necrotic teeth prior to clinical intervention, this measurement will be conducted using a portable occlusal force gauge (GM10). Following the completion of therapy, MBF measurements will be repeated at 6 and 12 months to assess long-term outcomes. Subsequently, the collected data will undergo comprehensive analysis.

Read the detailed description

The maximum bite force (MBF) or masticatory force results from the contact of the maxillary and mandibular teeth with the bones and muscles of the jaw [1,2,3].

Although, it is well known that the protective reflex with the jaw elevator muscle is initiated through the activation of mechanoreceptors located within the periodontal ligament [3,4,5,6]. Several studies in the literature have provided compelling evidence supporting the involvement of dental pulp in the reflex withdrawal reaction and its ability to mediate proprioceptive functions via intradental mechanoreceptors. These mechanoreceptors play a crucial role in transmitting tactile impulses through fast conducting A-delta and A-beta fibres, ultimately reaching the principal sensory nucleus of the trigeminal nerve [7-11].

Henceforth, subsequent carrying out of root canal treatment (RCT) and apexification, which are widely recognised as conventional treatment approaches for necrotic mature and immature teeth respectively, it seems that a portion of the protective mechanism and stress reduction effect is compromised due to the removal of pulpal tissue [12]. Consequently, diminished ability to control the strain exerted on dentin, along with changes in the mechanical and physical characteristics of dentin and loss of tooth structure during cavity preparation and instrumentation. Thus, the tooth becomes more susceptible to occlusal forces, thereby elevating the risk of fracture [13-15]. This has been tested by previous studies, which have demonstrated that MBF is greater in teeth that have undergone endodontic treatment than in vital contralateral teeth [8,16]. Therefore, the alternative path in which endodontics is moving is towards regenerative endodontic procedures (REPs) rather than replacing tissues with artificial alternatives.

Regenerative endodontic procedures are defined as "biologically based procedures designed to replace damaged structures, including dentin and root structures, as well as cells of the pulp-dentin complex" [17]. It capitalizes on the presence of undifferentiated mesenchymal stem cells (MSCs) within the periapical tissues. These cells gain access to the root canal after over-instrumentation of the apex [18]. Additionally, the growth factors present in the dentine play a pivotal role in directing the migration, proliferation, and differentiation of these stem cells, which possess the ability to regenerate the pulp-dentin complex.

REPs have been widely recognized as a clinically effective treatment modality, as numerous clinical studies and case reports have shown favorable outcomes in terms of root development, apical closure, periapical lesion healing, and symptoms resolution in the majority of treated mature and immature teeth [19-26].

The question arises as to the status of neural regeneration, there is a strong evidence that show that the formed pulp-like tissue after REPs has a sensory innervation, treated cases have demonstrated positive responses to sensibility tests, including cold or electric pulp test, indicating the potential reinnervation of the regenerated tissues [27, 28]. A study by Diogenes indicated that these vitality responses require targeting of the periapical neuronal terminals into coronal areas of the repaired tissue nearly 10-15 mm away from the closest nerve trunks [29]. A histological examination revealed the presence of organised nerve fibres in two teeth treated with REP [30], and another recent study demonstrated the presence of sensory fibers after REP of necrotic pulp [31].

Regaining sensitivity and nerve fibers suggested regaining the nerve function and pulp's proprioceptive defense against occlusal forces which will protect the pulp from damage and increases tooth fracture resistance [28].

Performance of revitalized teeth against occlusal loading has been studied by Finite element analysis (FEA), one study using 3D FEA that were developed from CBCT scans shows that immature teeth treated with revascularization has lower stress values and risk of fracture due to continual root development and change in root dimensions [32]. Another study concluded that following pulp revascularization, the deposition of dentin exhibits a substantial enhancement in mechanical resistance, this consequently leads to a more uniform distribution of stress during biting scenarios, as opposed to the condition observed in immature teeth [33].

Various devices have been employed to directly measure bite force in scientific studies, such as the bite fork, strain gauge transducers, foil transducers, the pressurized rubber tube, the gnathodynamometer, the pressure-sensitive sheet, and force sensing resistors. The present study aims to assess bite force using a bite fork device (GM10), which incorporates a hydraulic pressure gauge. Prior investigations have demonstrated that the aforementioned bite fork exhibits noteworthy test-retest reliability and has been validated by prior scholarly inquiries, thus establishing its suitability for facilitating endodontic clinical trials [16].

The research significance lies in the evident gap within the current body of knowledge concerning the biomechanical characteristics of teeth subjected to REPs versus conventional treatments. Furthermore, the limited available data on the capacity of regenerated pulp tissue, post-revascularization, to restore the pulp's proprioceptive defense against occlusal forces underscores the need for this investigation.

This prospective clinical trial involves measurements of MBF in necrotic mature and immature teeth undergoing either RCT or apexification, as well as revascularization. By doing so, it aims to shed light on the role of pulp revascularization in modulating occlusal loads in both mature and immature teeth. This examination of how regenerated pulp tissues may influence bite force values promises to provide valuable insights into this crucial aspect. Moreover, this methodology also serves to validate findings from previous studies exploring the impact of pulp on regulating bite force measurements

Being tested
measurement of maximum bite force using bite fork, conventional root canal treatment, pulp revascularization by induced bleeding, MTA apexification
Keywords
regenerative endodontic, maximum bite force
Medical subject headings
Dental Pulp Necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • measurement of maximum bite force using bite forkDiagnostic test

    using bite fork the bite force will be recorded for all teeth preoperative and post operative

  • conventional root canal treatmentProcedure or surgery

    General principles of conventional endodontic treatment will be applied in all cases, such as the administration of an appropriate local anaesthetic and rubber dam isolation. access and cleaning and shaping using rotary files and obturation. All cases will receive a permanent restoration as a final restoration and a post-operative periapical radiograph

  • pulp revascularization by induced bleedingProcedure or surgery

    Regeneration procedures will be conducted in two appointments, adhering to the 'Clinical Considerations for a Regenerative Procedure' proposed by the American Association of Endodontists (AAE) in 2021. All cases will receive a permanent restoration as a final restoration and a post-operative periapical radiograph

  • MTA apexificationProcedure or surgery

    MTA apical plug will be randomly applied to teeth with open apex

Study groups in NCT06934317
Study groupRoleWhat they receive
Induced bleeding mature and immature groupExperimentalRegeneration procedures will be conducted in two appointments, adhering to the 'Clinical Considerations for a Regenerative Procedure' proposed by the American Association of Endodontists (AAE) in 2021. All cases will receive a permanent restoration as a final restoration and a post-operative periapical radiograph
Receives: Diagnostic Test: measurement of maximum bite force using bite fork; Procedure: pulp revascularization by induced bleeding
root canal treated mature groupPlacebo comparatorconventional root canal treatment in mature necrotic teeth with periapical lesion
Receives: Diagnostic Test: measurement of maximum bite force using bite fork; Procedure: conventional root canal treatment
MtA apexificationPlacebo comparatorwhich includes the immature necrotic permanent teeth, will randomly receive either MTA apexification or revascularization
Receives: Diagnostic Test: measurement of maximum bite force using bite fork; Procedure: MTA apexification

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clinical signs and symptoms

    absence of pain, tenderness, and evidence of radiographic healing

    Measured: in 3, 6 and 12 months intervals

Secondary outcomes (1)
  1. assesment of pulp vitality

    using positive respone to cold test and electirc pulp tester

    Measured: in 6 and 12 months intervals

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2025
  2. Study start20 Dec 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06934317
Sponsor's protocol ID
KingAbdullahUH3
Status last verified
Apr 2025
First submitted
11 Apr 2025
Last updated
18 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing measurement of maximum bite force using bite fork, conventional root canal treatment and pulp revascularization by induced bleeding in people with Necrotic Pulp and Regenerative Endodontic Procedures, run by Lama Awawdeh at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical signs and symptoms (time frame: in 3, 6 and 12 months intervals). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.

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