Evaluation of the Effect of Labio-Lingual Spring Hawley and Clear Aligners on Periodontal Health and Salivary Parameters

Assessment of the Effect of Labio-Lingual Spring Hawley and Clear Aligners on Children's Oral Microflora and Salivary Parameters

Objective: The aim of our study was to determine the effect of two different types of removable appliances on periodontal health, dental plaque colonization, as well as saliva, pH, flow rate, and buffering capacity of the patients.

Method: A total of 30 pediatric patients aged 7-12 years were treated with a total of 30 appliances including 15 clear aligners (Group A) and 15 labiolingual spring hawleys (Group B). In the clinical examination of the patients, dental caries status was evaluated by DMFT and dft index, periodontal health status was evaluated by probing pocket depth measurements and plaque, gingival and probing bleeding indices. In addition, saliva and dental plaque samples were taken and salivary parameters and microbiologic structure of plaque were analyzed. All these procedures were performed in 2 different time periods for each patient; before and after the treatment. The results were statistically evaluated using SPSS (SPSS Statistics v23.0 for Windows, Chicago, IL, USA).

Study Overview

• Status: Completed
• Conditions: Anterior Crossbite
• Intervention / Treatment: Device: Clear aligner; Device: Labiolingual spring hawley

Detailed Description

In the clinical examination of the participants, dental caries status was evaluated by DMFT and dft index, and periodontal health status was evaluated by probing pocket depth measurements; PI, GI, SDI. In addition, saliva and dental plaque samples were taken and salivary parameters (flow rate, pH and buffering capacity) and microbiological structure of plaque were analyzed.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konyaaltı
    • Antalya, Konyaaltı, Turkey, 07058
      • Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Dental anterior crossbite

Exclusion Criteria:

• Skeletal anterior crossbite
• Systemic disease
• Regular medication use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clear aligner users; Patients who were treated with clear aligners were referred to as 'clear aligner users'.	Device: Clear aligner; The effects of treatment on periodontal parameters (plaque index, gingival index, bleeding index on probing), salivary parameters (stimulated/unstimulated flow rate, stimulated/unstimulated pH, buffering capacity) and oral microorganism counts (S. mitis, S. salivarius, S. mutans, C. albicans) of children treated with labiolingual spring hawley and clear aligners were investigated.
Experimental: Labiolingual spring hawley users; Patients who were treated with clear aligners were referred to as 'Labiolingual spring hawle users'.	Device: Labiolingual spring hawley; The effects of treatment on periodontal parameters (plaque index, gingival index, bleeding index on probing), salivary parameters (stimulated/unstimulated flow rate, stimulated/unstimulated pH, buffering capacity) and oral microorganism counts (S. mitis, S. salivarius, S. mutans, C. albicans) of children treated with labiolingual spring hawley and clear aligners were investigated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PIaque index (PI)	Based on Silness-Löe (1963, 1967) PI values, bacterial plaque and plaque thickness in direct contact with the marginal gingiva are evaluated. The evaluation is made with the Williams-marked University of Michigan 'O' periodontal probe, and PI values are recorded from a total of 4 surfaces of each tooth included in the study, namely mesial, distal, buccal and lingual. The averages of these values are calculated for each patient. The average scores obtained are evaluated in the 0-3 score range. An increase in the calculated scores indicates that periodontal health is negatively affected.	3 months
DMFT index	To determine the DMFT index score, decayed teeth in permanent teeth are indicated as "D", lost teeth extracted due to decay are indicated as "M", and filled teeth are indicated as "F". The DMFT index is calculated by adding the D, M, F values and dividing them by the total number of permanent teeth. An increase in the calculated scores indicates that oral and dental health is negatively affected.	3 months
Oral microorganisms count	S. mitis, S. salivarius, S.mutans, C. albicans (cfu/ml)	3 months
Gingival index (GI)	The degree of gingivitis is assessed using the Silness-Löe (1963, 1967) GI. The average of the measurements taken from four sides of the tooth determines the GI score of the tooth, and the average of the measurements of all teeth determines the individual's gingival index score. The scores obtained are evaluated in the range of 0-3. An increase in the calculated scores indicates that periodontal health is negatively affected.	3 months
Bleeding on probing index (BOP)	In order to determine the inflammatory status of the pocket base and pocket epithelium, a score is given as positive (+) or negative (-) according to whether there is bleeding in the sulcus 20 seconds after the pocket depth measurement from a total of 4 surfaces of the teeth, mesial, distal, buccal and lingual. BOP is calculated as a score by dividing the number of bleeding teeth by the total number of tooth surfaces in each patient. An increase in the calculated scores indicates that periodontal health is negatively affected.	3 months
dft index	The dft Index is the calculated form of the DMFT index for primary teeth. When calculating the dft group index, missing teeth are not included in the calculation. Because it is difficult to diagnose the reason for the loss of primary teeth and there is a high probability of error. For this reason, the number of decayed and filled teeth is calculated during the examination. Decayed teeth are indicated with "d" and filled teeth with "f". The dft index is calculated by adding the d and f values and dividing them by the total number of permanent teeth. An increase in the calculated scores indicates that oral and dental health is negatively affected.	3 months

Collaborators and Investigators

• Sponsor: Ozge Gungor
• Collaborators: Akdeniz University
• Investigators: Principal Investigator: Özge GÜNGÖR, DDS, Assoc. Prof. Dr., Akdeniz University Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Actual): June 10, 2024
• Study Completion (Actual): November 10, 2024

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: March 1, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Oral health; Clear aligner; Labiolingual spring hawley
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: AkdenizUıremkapıcı001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No