Clinical and Radiographic Assessment of PRF Versus Lutein Placement

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

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.

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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

Study Overview

• Status: Completed
• Conditions: Osteogenesis
• Intervention / Treatment: Biological: Platelet rich fibrin; Dietary supplement: Lutein / Zeaxanthin

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

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Faculty of Dentistry,Mansoura university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; Immediate implant placement with leaving the gap distance empty
Experimental: PRF group; Immediate implant placement then placement of PRF around the implant in the gap distance	Biological: Platelet rich fibrin; platelet rich fibrin extracted from patient's blood after centrifuging
Experimental: lutein group; Immediate implant placement then placement of lutein around the implant in the gap distance	Dietary supplement: Lutein / Zeaxanthin; lutein extract from lutein oral capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone formation	bone formation will be assessed by using conebeam CT	12 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: M18080921

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No