Clinical trial NCT04971382: Alveolar Ridge Augmentation With Curcumin Combined With Xenograft
Official title: Alveolar Ridge Augmentation With Curcumin Combined With Xenograft After Piezoelectric Alveolar Ridge Splitting Surgery (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Horizontal Alveolar Bone Loss
Keywords: curcumin
xenograft
Piezoelectric
Alveolar Ridge Splitting
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study was performed to investigate the effect of curcumin on the osteogenic differentiation of human periodontal ligament stem cells (hPDLSCs) and its underlying potential mechanism. The Results was that Curcumin at an appropriate concentration had no cytotoxicity and could promote osteogenic differentiation of the hPDLSCs

Detailed description: Patients will be selected from the outpatient clinic of Oral Medicine, Periodontology and Oral diagnosis Department, Faculty of Dentistry, Ain Shams University. The purpose of the study will be explained to all patients and an informed consent will be signed before the conduction of the study .The faculty research ethics committee will review the proposal.

The study will be conducted in the form of Patient Intervention Comparative Outcome (PICO) question (Patient "P", Intervention "I", Comparative "C", Outcome "O"). (Stone 2002) "P": Patient in the study will have enough alveolar ridge height ,suffering from missing from 1 to 3 upper maxillary anterior and /or premolar with insufficient alveolar ridge buccolingual (BL) width that interfere with conventional straight forward implant placement. The minimum BL width included in the study will be 4 mm. "I": Ridge splitting with interposition grafting with curcumin and particulate xenograft grafting. "C":Alveolar ridge splitting with interposition grafting with use of particulate xenograft alone without curcumin . "O":Clinical and radiographic outcome.

Eligibility criteria: Inclusion Criteria:

* Male and female with age range 25-45 years.
* Patient with enough alveolar ridge height, suffering from missing single or multiple maxillary anterior and /or premolar with insufficient alveolar ridge buccolingual (BL) width that interfere with conventional straight forward implant placement. The minimum BL width included in the study will be 4-5 mm to facilitate ridge splitting and expansion.
* Systemically free from any diseases as evidenced by Burket's oral medicine health history questionnaire.
* Patient available during follow up periods.

Exclusion Criteria:

* Smokers.
* Pregnant and breast feeding females.
* Patient unwilling to comply to oral hygienic instructions.
* Patients under any medication or medical condition that affect the bone quality.
* Vulnerable groups. (e.g decisions impaired individual).

Primary outcomes:
measure: clinical outcome
timeFrame: change from baseline at 6 months
Secondary outcomes:
measure: stability
timeFrame: "through study completion, an average of 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry Ain shams university
Study officials:
affiliation: faculty of dentistry . Ain Shams University
name: Hala A Abuelela, professor
role: STUDY_DIRECTOR
References: