Clinical and Radiographic Assessment of PRF Versus Lutein Placement

NCT06358352 | Completed

• 1 other identifier: M18080921
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Osteogenesis

Outcome Measures

Primary Outcomes (1)

• bone formation

  bone formation will be assessed by using conebeam CT

  12 months

Study Arms (3)

control group

NO INTERVENTION

Immediate implant placement with leaving the gap distance empty

PRF group

EXPERIMENTAL

Immediate implant placement then placement of PRF around the implant in the gap distance

Biological: Platelet rich fibrin

lutein group

EXPERIMENTAL

Immediate implant placement then placement of lutein around the implant in the gap distance

Dietary Supplement: Lutein / Zeaxanthin

Interventions

Lutein / Zeaxanthin DIETARY_SUPPLEMENT

lutein extract from lutein oral capsules

lutein group

Platelet rich fibrin BIOLOGICAL

platelet rich fibrin extracted from patient's blood after centrifuging

PRF group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Badly destructed maxillary single rooted teeth due to trauma or caries.
• Age between 20 and 45 years.
• Good oral hygiene.
• Patients willing to complete the study follow up intervals.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

faculty of dentistry,Mansoura university

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

Lutein; Zeaxanthins

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of oral and maxillofacial surgery

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: October 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

EG (1)