Periodontal Health
Conditions
Keywords
platelet-rich fibrin, vitamin D3, periodontal health
Brief summary
The study aims to evaluate the effect of using PRF and vitamin Dꝫ injections on periodontal health and parameters and compare them when used to facilitate orthodontic treatment.
Detailed description
* Participants will be recruited from the Faculty of Dentistry, Beni-Suef University. All subjects will be informed of the treatment procedures and will sign a consent form. * Subjects will be randomly divided into two groups: Group 1 (PRF group): upper canine retraction will be facilitated by PRF injection that will be randomly assigned to one side (experimental side). The contralateral side will serve as the control one. Group II (Vitamin Dꝫ group): canine retraction will be facilitated by Vitamin Dꝫ injection that will be randomly assigned to one side (experimental side). The contralateral side will serve as the control one. * The predicted sample size (n) was a total of (28) cases (i.e. 14 cases per group). Sample size calculation was performed using G\*Power version 3.1.9.7 * Simple randomization will be designed with the aid of a computer-generated schedule with 1:1 allocation ratio. Allocation concealment will be achieved using identical opaque, sealed envelopes. Randomization and allocation concealment will be performed by one of the academic staff who will not be involved in the study and will keep the allocation table away from the operators. The operator will shuffle the sealed envelopes and will ask the patient to pick one envelope at the time of recruitment. In each group, a randomly selected side will act as the experimental side while the contralateral side will serve as the control. Blinding of the operators will not be applicable and so blinding will be limited to the outcome assessment. Methodology: * All patients will be treated with a 0.022-inch MBT bracket system. Leveling and alignment phase will be completed until a 0.017 X 0.025''stainless steel wire will be inserted passively into the bracket slot. Before canine retraction, the subject will be randomly assigned to one of the groups (PRF or Vitamin Dꝫ group). In both groups, canine retraction will be performed with closed Ni-Ti coil springs with a force of 150 g per side that will be adjusted by the use of a force gauge.
Interventions
OTHERPlatelet-rich Fibrin
PRF will be injected distal to the canine on the experimental side.
OTHERVitamin D3
Vitamin Dꝫ will be injected distal to the canine on the experimental side
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single-blinded limited to the outcome assessment
Intervention model description
split-mouth, prospective, single-center, single-blinded, two-arm randomized clinical trial with a 1:1 allocation ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18- 40 years old. 2. Angle Class I or Class II dental malocclusion that required bilateral maxillary first premolar extraction and upper canine retraction as a part of the treatment plan. 3. Good to fair oral hygiene. 4. Normal probing depth.
Exclusion criteria
1. Active periodontal disease. 2. Poor oral hygiene. 3. Systemic diseases or medications that alter bone metabolism or tooth movement. 4. Craniofacial anomalies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effect of using PRF and Vitamin Dꝫ injections on periodontal health and compare them. | 3 - 4 months | Clinical periodontal examination of the upper canines will be done before and after retraction on the experimental and control sides by recording the probing depth (PD). • The probing depth will be measured from the gingival margin to the base of the gingival sulcus in millimeters by using a manual periodontal probe (William's probe). The measurements will be recorded at 6 sites around the tooth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigate the effect of PRF and Vitamin Dꝫ injections on the gingival thickness. | 3 - 4 months | The gingival thickness will be recorded using an endodontic file with a stopper, which is placed horizontally, perpendicular to the long axis of the tooth on the labial gingiva. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effect of using PRF and Vitamin Dꝫ injections on the width of keratinized mucosa (KM) | 3 - 4 months | The width of keratinized mucosa (KM) on the facial aspect will be measured in millimeters at the mid-facial aspects from the mucogingival junction to the free gingival margin using a periodontal probe before and after canine retraction. |
| Evaluate the effect of using PRF and Vitamin Dꝫ injections on the gingival index. | 3 - 4 months | The gingival index will be evaluated by the following scores before and after canine retraction: 0: Normal gingival, no inflammation, no discoloration, no bleeding. 1. Mild inflammation, slight color change, mild alteration of gingival surface, no bleeding. 2. Moderate inflammation, erythema, swelling, bleeding on probing or when pressure is applied 3. severe inflammation, severe erythema, swelling, tendency towards spontaneous bleeding some ulceration. |
| Evaluate the effect of using PRF and Vitamin Dꝫ injections on the plaque index. | 3 - 4 months | Plaque index will be evaluated by the following scores before and after canine retraction: 0: No dental plaque 1. Thin film of plaque at the gingival margin not visible by naked eye and detect by probe 2. Moderate film of plaque at the gingival margin, interdental space free of plaque visible by naked eye 3. Heavy plaque accumulation at the gingival margin on interdental space filled with plaque (calculus) |
| Evaluate the effect of using PRF and Vitamin Dꝫ injections on the clinical attachment level (CAL) | 3 - 4 months | Clinical attachment level (CAL) will be measured from the cementoenamel junction to the base of the periodontal pocket in millimeters by using a periodontal probe. |
Countries
Egypt
Contacts
Primary ContactRehab Khalil
Backup ContactMaha Abdelkawy
Outcome results
None listed