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Clinical and Radiographic Assessment of PRF Versus Lutein Placement

Clinical and Radiographic Assessment of PRF Versus Lutein Placement Around Immediately Placed Dental Implants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06358352
Enrollment
30
Registered
2024-04-10
Start date
2021-10-01
Completion date
2023-05-01
Last updated
2024-04-10

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

Conditions

Osteogenesis

Brief summary

Thirty patients seeking for prosthetic replacement of non-restorable single rooted maxillary teeth by dental implant placement will be selected from the Out-Patient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University. Inclusion criteria: 1. Badly destructed maxillary single rooted teeth due to trauma or caries. 2. Age between 20 and 45 years. 3. Good oral hygiene. 4. Patients willing to complete the study follow up intervals. 5. Patients will be informed about the aim of the study and a written consent will be obtained. The patients have the right to withdraw from the study at any time. Exclusion criteria: 1. periapical infection in the teeth to be replaced. 2. Alcohol or drug abuse. 3. Patients with systemic diseases that absolutely contraindicate implant placement 4. Pregnancy. 5. Patients with parafunctional habits (bruxism and clenching) 6. Uncooperative patients 7. Heavy smokers. 7 Patients grouping: Patients will be randomly divided into three groups: Group A: Immediate implant placement with leaving the gap distance empty Group B: Immediate implant placement then placement of PRF around the implant in the gap distance Group C: Immediate implant placement then placement of lutein around the implant in the gap distance Clinical evaluation: Patients will be evaluated clinically for: 1-Postoperative Pain: By using a 10-point Visual Analogue Scale (VAS) for assessment of pain by the patient on the 1st, 3rd, and 7th days after surgery.(10) (0-1=None, 2-4=Mild, 5-7=Moderate, 8-10=Severe) 2. Implant stability Will be assessed at the time of implant insertion and at a period of 3, 6 and 12 months intervals. Resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) will be recorded by a transducer attached to the implant by a screw and a frequency response analyzer (Osstell Mentor Device) with the average of 2 measurements performed with the probe in 2 perpendicular directions. 3\. Sulcus Bleeding Index (SBI) An early sign of gingivitis is bleeding on probing and, in 1971, Muhlemann and Son described the Sulcus Bleeding Index (SBI). It will be assessed at 3, 6 and 12 months intervals. 4\. Peri-implant probing depth: Depth of the peri-implant sulcus will be made at 3, 6 and 12 months intervals with light force to avoid undue tissue damage and over-extension into the healthy tissue. Radiographic evaluation: conebeam CT will be done to evaluate the vertical and horizontal changes to the alveolar bone following immediate implant placement. It will be done immediately after implant placement , after 3 months and after 12 months

Interventions

DIETARY_SUPPLEMENTLutein / Zeaxanthin

lutein extract from lutein oral capsules

BIOLOGICALPlatelet rich fibrin

platelet rich fibrin extracted from patient's blood after centrifuging

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

1. Badly destructed maxillary single rooted teeth due to trauma or caries. 2. Age between 20 and 45 years. 3. Good oral hygiene. 4. Patients willing to complete the study follow up intervals. 5. Patients will be informed about the aim of the study and a written consent will be obtained. The patients have the right to withdraw from the study at any time.

Exclusion criteria

1. periapical infection in the teeth to be replaced. 2. Alcohol or drug abuse. 3. Patients with systemic diseases that absolutely contraindicate implant placement 4. Pregnancy. 5. Patients with parafunctional habits (bruxism and clenching) 6. Uncooperative patients 7. Heavy smokers.

Design outcomes

Primary

MeasureTime frameDescription
bone formation12 monthsbone formation will be assessed by using conebeam CT

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026