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RetrognathismPhase 2/3NCT05536596

Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy

A Phase 2/3 study testing Orthognathic Surgery, Melatonin 10 MG Oral Tablet and Hydroxycobalamin in people with Retrognathism and Prognathism, run by Universitat Internacional de Catalunya.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The bilateral sagittal split osteotomy (BSSO) of the mandible is one of the most used surgical techniques to achieve a harmonious jaw relation in the context of orthognathic surgery. Read more about this study

Who is it for?
Ages 13 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Retrognathism, Prognathism, Orthognathic Surgery
What is being tested?
Orthognathic Surgery, Melatonin 10 MG Oral Tablet and Hydroxycobalamin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
No sites listed yet
Study dates
30 Sep 2022to 31 Dec 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

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 13 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • patients who:
  • do not have sufficient information in their clinical records
  • cannot be contacted
  • do not attend their check-ups (for at least 24 postoperative months in cases with DNS)
  • have refused consent to the use of their information for purposes of research.
  • already undergoing Orthognathic Surgery
  • with systemic conditions prone to alter recovery patterns or serious systemic diseases (decompensated metabolic disorders; neoplasms; osteodysplasias; neuropathies).
  • pregnancy

Trial locations and contacts

No sites are listed yet.

Pedro Sole, DMD, OMFS contact

+56 9 9235 2728

psole@uic.es

Maximiliano Bravo, DMD contact

+56 9 7690 0878

mabravo9@uc.cl

About this study

Official title: Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy: a Randomized, Double-blind Trial

The bilateral sagittal split osteotomy (BSSO) of the mandible is one of the most used surgical techniques to achieve a harmonious jaw relation in the context of orthognathic surgery. Nevertheless, one of its main complications is neurosensory damage to the inferior alveolar nerve, which can cause severe impact in the quality of life on patients who suffer from it permanently. The purpose of this randomized clinical trial is to provide rigorous scientific evidence of the pharmacological effect of 1) Melatonin, 2) combination uridine triphosphate (UTP), cytidine monophosphate (CMP), and hydroxycobalamin (UTP/CMP/hydroxycobalamin) and 3) hydroxycobalamin regarding neurosensory disturbances incidence and persistence after BSSO.

Read the detailed description

The study will be done according to the international standards of the Helsinki convention for medical research and approved by the scientific ethics committee of Universidad de los Andes Clinic.

All subjects will give their signed consent to participate of this clinical research.

This clinical randomized trial will be double-blinded as both the patient and the surgeon will not know the treatment used until the experiment is over. The randomization will be done using "random.org" software to assign participants into 4 groups. Groups A, B and C will receive the medication, whereas the Group P will receive a placebo.

Being tested
Orthognathic Surgery, Melatonin 10 MG Oral Tablet, Hydroxycobalamin, Centrum
Keywords
Bilateral Sagittal Split Osteotomy, Neurosensory Disturbances
Medical subject headings
Retrognathia, Prognathism, Sensation Disorders

What participants receive

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

  • Orthognathic SurgeryProcedure or surgery

    Also called Bilateral Sagittal Split Osteotomy

    Prognathism/Retrognathism correction through surgical procedures

  • Melatonin 10 MG Oral TabletDrug

    Group B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.

  • HydroxycobalaminDrug

    Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.

  • CentrumDrug

    Also called Citoneurone [Cytidine + Hydroxocobalamin, + Uridine]

    Groups A will receive the pharmacology treatment with 1.5 mg uridine triphosphate, 2.5 mg cytidine monophosphate and 1 mg hydroxycobalamin (Citoneuron). One capsule orally three times a day for 60 days as suggested by the manufacturer for patients with trauma - compressive peripheral neural disorders.

Study groups in NCT05536596
Study groupRoleWhat they receive
CitoneuroneExperimentalGroups A will receive the pharmacology treatment with 1.5 mg uridine triphosphate, 2.5 mg cytidine monophosphate and 1 mg hydroxycobalamin (Citoneurone). One capsule orally three times a day for 60 days as suggested by the manufacturer for patients with trauma - compressive peripheral neural disorders.
Receives: Procedure: Orthognathic Surgery; Drug: Centrum
MelatoninExperimentalGroup B will receive the pharmacology treatment with 10 mg Melatonin. One capsule orally at night for 60 days.
Receives: Procedure: Orthognathic Surgery; Drug: Melatonin 10 MG Oral Tablet
HydroxycobalaminExperimentalGroup C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12). One capsule daily for 60 days.
Receives: Procedure: Orthognathic Surgery; Drug: Hydroxycobalamin
PlaceboPlacebo comparatorThe controls will receive 1 capsule placebo containing 5 mg starch to be taken once daily.
Receives: Procedure: Orthognathic Surgery

What is being measured

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

  1. Neurosensory Activity

    Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others

    Measured: pre-operative

  2. Neurosensory Activity

    Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others

    Measured: 1 day postoperative

  3. Neurosensory Activity

    Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others

    Measured: 3 day postoperative

  4. Neurosensory Activity

    Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others

    Measured: 2 weeks postoperative.

  5. Neurosensory Activity

    Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others

    Measured: 1 month postoperative

  6. Neurosensory Activity

    Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others

    Measured: 2 month postoperative

  7. Neurosensory Activity

    Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others

    Measured: 6 month postoperative

  8. Neurosensory Activity

    Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others

    Measured: 12 month postoperative

  9. Neurosensory Activity

    Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others

    Measured: 18 month postoperative

Secondary outcomes (2)

  1. Subjective Test

    Subjective testing using a questionnaire and visual analogue scale. 0 = normal sensation, 10= more severe sensory deficit.

    Measured: pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.

  2. Objetive Test

    The Semmes-Weinstein (SW) test of sensitivity to touch/pressure will be used.

    Measured: pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.

Timeline

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

  1. First posted13 Sep 2022
  2. Study start30 Sep 2022 (estimated)
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion31 Dec 2024 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The participants will be assigned into 4 groups. Groups A, B and C will receive the medication (Melatonin, Hydroxycobalamin and combination UTP/CMP/hydroxycobalamin), whereas the Group P will receive placebo.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05536596
Sponsor's protocol ID
PISV01
Status last verified
Sep 2022
First submitted
1 Sep 2022
Last updated
13 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be available due to anonymity and ethical considerations.

Publications

  • Alolayan AB, Leung YY. Resolution of neurosensory deficit after mandibular orthognathic surgery: A prospective longitudinal study. J Craniomaxillofac Surg. 2017 May;45(5):755-761. doi: 10.1016/j.jcms.2017.01.032. Epub 2017 Feb 12.

    PubMed 28318920

  • Teerijoki-Oksa T, Jaaskelainen SK, Forssell K, Forssell H, Vahatalo K, Tammisalo T, Virtanen A. Risk factors of nerve injury during mandibular sagittal split osteotomy. Int J Oral Maxillofac Surg. 2002 Feb;31(1):33-9. doi: 10.1054/ijom.2001.0157.

    PubMed 11936397

  • da Costa Senior O, Gemels B, Van der Cruyssen F, Agbaje JO, De Temmerman G, Shaheen E, Lambrichts I, Politis C. Long-term neurosensory disturbances after modified sagittal split osteotomy. Br J Oral Maxillofac Surg. 2020 Oct;58(8):986-991. doi: 10.1016/j.bjoms.2020.05.010. Epub 2020 Jul 4.

    PubMed 32631751

  • Seddon HJ. A Classification of Nerve Injuries. Br Med J. 1942 Aug 29;2(4260):237-9. doi: 10.1136/bmj.2.4260.237. No abstract available.

    PubMed 20784403

  • Schlund M, Grall P, Ferri J, Nicot R. Effect of modified bilateral sagittal split osteotomy on inferior alveolar nerve neurosensory disturbance. Br J Oral Maxillofac Surg. 2022 Oct;60(8):1086-1091. doi: 10.1016/j.bjoms.2022.04.001. Epub 2022 Apr 13.

    PubMed 35606209

  • Ylikontiola L, Kinnunen J, Oikarinen K. Factors affecting neurosensory disturbance after mandibular bilateral sagittal split osteotomy. J Oral Maxillofac Surg. 2000 Nov;58(11):1234-9; discussion 1239-40. doi: 10.1053/joms.2000.16621.

    PubMed 11078134

  • Yoshioka I, Tanaka T, Khanal A, Habu M, Kito S, Kodama M, Oda M, Wakasugi-Sato N, Matsumoto-Takeda S, Seta Y, Tominaga K, Sakoda S, Morimoto Y. Correlation of mandibular bone quality with neurosensory disturbance after sagittal split ramus osteotomy. Br J Oral Maxillofac Surg. 2011 Oct;49(7):552-6. doi: 10.1016/j.bjoms.2010.09.014. Epub 2010 Nov 10.

    PubMed 21071118

  • van Merkesteyn JP, Zweers A, Corputty JE. Neurosensory disturbances one year after bilateral sagittal split mandibular ramus osteotomy performed with separators. J Craniomaxillofac Surg. 2007 Jun-Jul;35(4-5):222-6. doi: 10.1016/j.jcms.2007.04.006. Epub 2007 Jul 30.

    PubMed 17681774

  • Colella G, Cannavale R, Vicidomini A, Lanza A. Neurosensory disturbance of the inferior alveolar nerve after bilateral sagittal split osteotomy: a systematic review. J Oral Maxillofac Surg. 2007 Sep;65(9):1707-15. doi: 10.1016/j.joms.2007.05.009.

    PubMed 17719387

  • Panula K, Finne K, Oikarinen K. Neurosensory deficits after bilateral sagittal split ramus osteotomy of the mandible--influence of soft tissue handling medial to the ascending ramus. Int J Oral Maxillofac Surg. 2004 Sep;33(6):543-8. doi: 10.1016/j.ijom.2003.11.005.

    PubMed 15308252

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Orthognathic Surgery, Melatonin 10 MG Oral Tablet and Hydroxycobalamin in people with Retrognathism and Prognathism, run by Universitat Internacional de Catalunya.

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 0 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Pedro Sole, DMD, OMFS (+56 9 9235 2728, psole@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurosensory Activity (time frame: pre-operative). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05536596, which also lists 10 linked publications.

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 13 Sep 2022.

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