ClinicalTrials.Veeva

Menu

Rapid Maxillary Expansion Related Oxidative Stress and Periodontal Results

R

Recep Tayyip Erdogan University Training and Research Hospital

Status

Completed

Conditions

Maxillary Expansion

Treatments

Other: Periodontal measurements (plaque index, gingival index and probing pocket depth scores )
Procedure: Rapid maxillary expansion with Hyrax appliance
Other: Biochemical Sample Supply (Collection of serum and saliva samples)

Study type

Interventional

Funder types

Other

Identifiers

NCT06937775
BAP 2015/306

Details and patient eligibility

About

The aim of this study was to investigate the effects of rapid maxillary expansion on local and systemic oxidative stress levels. Thirty-five volunteer patients (17 females and 18 males) who needed rapid maxillary expansion will be included in the study. Serum and saliva samples will be collected from each patient during four different periods: a week before the treatment (T0), on the day of sutural separation (T1), at the end of the active expansion period (T2), and after the completion of a 3-month retention period (T3). To evaluate the patients' periodontal status, plaque index, gingival index, and probing pocket depth scores will be recorded for each period. 8-hydroxydeoxyguanosine (8-OHdG), total oxidative status (TOS), total antioxidant capacity (TAS), and oxidative stress index (OSI) biomarkers will be evaluated to determine the local and systemic oxidative stress levels.

Enrollment

35 patients

Sex

All

Ages

11 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Being between 11-15 years of age,
  • Having an indication for maxillary expansion due to maxillary stenosis,
  • Being highly cooperative, performing adequate oral care,
  • Being periodontally healthy,
  • Not having cleft lip and/or palate anomalies,
  • Not having any systemic disease,
  • Not having used any medication including antibiotics and anti-inflammatory drugs in the last 6 months,
  • Not being substance addicted and not smoking.

Exclusion criteria

  • Having inadequate oral hygiene
  • Being periodontally unhealthy
  • Having cleft lip and/or palate anomalies,
  • Having any systemic disease,
  • Having used any medication including antibiotics and anti-inflammatory drugs in the last 6 months,
  • Being substance addicted and not smoking.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

35 participants in 4 patient groups

TO
Other group
Description:
1 week before the placement of the Hyrax appliance
Treatment:
Other: Biochemical Sample Supply (Collection of serum and saliva samples)
Other: Periodontal measurements (plaque index, gingival index and probing pocket depth scores )
T1
Other group
Description:
The day of the first clinical observation of sutural opening (5-7 days after activation)
Treatment:
Other: Biochemical Sample Supply (Collection of serum and saliva samples)
Procedure: Rapid maxillary expansion with Hyrax appliance
Other: Periodontal measurements (plaque index, gingival index and probing pocket depth scores )
T2
Other group
Description:
The day of completion of active expansion (3-4 weeks)
Treatment:
Other: Biochemical Sample Supply (Collection of serum and saliva samples)
Procedure: Rapid maxillary expansion with Hyrax appliance
Other: Periodontal measurements (plaque index, gingival index and probing pocket depth scores )
T3
Other group
Description:
The day of completion of the 3-month reinforcement period
Treatment:
Other: Biochemical Sample Supply (Collection of serum and saliva samples)
Procedure: Rapid maxillary expansion with Hyrax appliance
Other: Periodontal measurements (plaque index, gingival index and probing pocket depth scores )

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems