Effect of extraction timing on alkaline phosphatase enzyme levels in the fluid around the gums during orthodontic treatment

Alkaline phosphatase activity in gingival crevicular fluid during orthodontic alignment and extraction protocols: a randomized controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17615120

Enrollment

Registered

2025-10-30

Start date

2022-12-01

Completion date

Unknown

Last updated

2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluation of gingival crevicular fluid alkaline phosphatase activity in patients with moderate maxillary dental crowding undergoing orthodontic treatment with different extraction timing protocols. Oral Health

Interventions

Randomization was performed using sealed opaque envelopes to ensure allocation concealment. Blinding was applied to the laboratory examiner analyzing ALP activity, while operator and patients were not

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy male and female participants aged 18–28 years 2. Presence of moderate maxillary dental crowding as defined by Little’s Irregularity Index between 4–6 mm 3. Indication for orthodontic treatment with extraction of upper first premolars for space management 4. Good oral hygiene and healthy periodontium (probing depth = 3 mm, no bleeding on probing) 5. No systemic diseases or medications affecting bone metabolism 6. No previous orthodontic treatment 7. Willingness to participate and sign informed consent

Exclusion criteria

Exclusion criteria: 1. Presence of severe or mild dental crowding (Little’s Irregularity Index 6 mm) 2. Systemic diseases or conditions affecting bone metabolism (e.g., diabetes, osteoporosis, hyperparathyroidism) 3. Current or previous use of medications that influence bone turnover (e.g., corticosteroids, bisphosphonates, anticonvulsants) 4. Poor oral hygiene or active periodontal disease 5. Pregnant or lactating females 6. History of orthodontic treatment or trauma to the anterior maxillary teeth 7. Smoking or use of tobacco products 8. Refusal or inability to sign informed consent

Design outcomes

Primary

Measure	Time frame
Alkaline phosphatase (ALP) activity in gingival crevicular fluid (GCF) measured using a spectrophotometric enzymatic assay (Jenway 6330, 405 nm) at seven timepoints: baseline (T0) and weekly intervals up to 6 weeks (T1–T6) during orthodontic leveling and alignment.	—

Secondary

Measure	Time frame
Changes in gingival crevicular fluid alkaline phosphatase (ALP) activity over time, measured using a spectrophotometric enzymatic assay (Jenway 6330, 405 nm) at seven time points: baseline (T0) and weekly up to 6 weeks (T1–T6).	—

Countries

Syria

Contacts

Public ContactYahya Dakdouk

yahya1.dakdouk@damascusuniversity.edu.sy+963 (0)91833272

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026