Determining the Presence of RAP in Orthognathic Patients... | NCT04823325

Studies
Determining the Presence of RAP in Orthognathic Patients and Its Effect on Root Resorption by Biomarkers

NCT04823325

Sponsor

Bezmialem Vakif University

Status

Completed

Last Update Posted

Mar 30, 2021Actual

Enrollment

13Actual

Phase

Not provided

Conditions

Class III Malocclusion
Root Resorption

Interventions

Orthognathic Surgery

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2019Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Jan 1, 2021Actual

First Submitted Date

Mar 10, 2021

First Submission Date that Met QC Criteria

Mar 29, 2021

First Posted Date

Mar 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2021

Last Update Posted Date

Mar 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A prospective clinical trial to what extent inflammatory biomarkers are affected by the medication after orthognathic surgery in early surgical cases and whether these biomarkers affects the amount of maxillary or mandibular incisor root resorption.

Detailed Description

To conduct a prospective clinical trial to what extent inflammatory biomarkers such as OPG, RANKL, IL-1, IL-6, and CRP are affected by the medication after orthognathic surgery in early surgical cases and whether these biomarkers affects the amount of maxillary or mandibular incisor root resorption.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgery patients		Otherwise healthy patients with Skeletal Class III problem	Procedure: Orthognathic Surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Orthognathic Surgery	Procedure	The duration for presurgical orthodontic treatment was; 7,7 ± 1,7 months.	Surgery patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessing Change Between Three Time Points of Biomarkers to Determine Effectiveness of Regional Acceleratory Phenomenon	IL- 6 RANKL	To see the change at biomarker levels GCF samples were collected at the time points designated as T0, T1, and T2 which correspond to the day of the surgery before anesthesia, 1 week after the surgery, and 4 weeks after the surgery
Assessing Change Between Two Time Points to Determine Root Resorption	Morphologic changes in root apex	To see the change of root length all radiographs were taken digitally at t0 (at the beginning of orthodontic preparation), t1 (just before the orthognathic surgery), and t2 ( an average of 1,5 years postop) with an X-ray unit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Have skeletal Cl III malocclusion
Wisdom teeth are absent or extracted at least 6 months before the surgery
Need of orthognathic surgery through Le Fort I osteotomy of the maxilla and bilateral sagittal split osteotomies (BSSO) of the mandible.
Undergo fixed orthodontic treatment before and after the orthognathic surgery
Have available orthopantomograms with adequate quality
Have healthy periodontal tissue without inflammation or bleeding before and after the surgery.
Maintain the same medication protocol during and after the surgery.

Exclusion Criteria:

ongoing use of regular medication
smoking
known penicillin allergy,
any immune disorder,
musculoskeletal diseases,
syndromes,
cleft lip-palate,
systemic diseases affecting root resorption,
periodontal and gingival disorders,
missing teeth among upper or lower incisors,
poor oral hygiene.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

The study was started by collecting GCF before surgery from 25 patients. Patients who developed exclusion criteria while the study was in progress were excluded from the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Banu Kilic	Bezmialem Vakif University	Study Director
Nisa Gül Amuk	TC Erciyes University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Banu Kilic		Istanbul	Fatih	34844	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Dec 29, 2021
Reset	Mar 11, 2022

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 29, 2021			Mar 11, 2022

Condition Browse Module

MeSH Terms

ID	Term
D008313	Malocclusion, Angle Class III
D012391	Root Resorption

Ancestor Terms

ID	Term
D008310	Malocclusion
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D014091	Tooth Resorption

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D013515	Surgery, Oral
D003813	Dentistry