Clinical and Radiographic Assessment of PRF Versus Lutein Placement

NCT ID: NCT06358352

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

control group

Immediate implant placement with leaving the gap distance empty

Group Type: NO_INTERVENTION

No interventions assigned to this group

PRF group

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

Group Type: EXPERIMENTAL

Platelet rich fibrin

Intervention Type: BIOLOGICAL

platelet rich fibrin extracted from patient's blood after centrifuging

lutein group

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

Group Type: EXPERIMENTAL

Lutein / Zeaxanthin

Intervention Type: DIETARY_SUPPLEMENT

lutein extract from lutein oral capsules

Interventions

Lutein / Zeaxanthin

lutein extract from lutein oral capsules

Intervention Type: DIETARY_SUPPLEMENT

Platelet rich fibrin

platelet rich fibrin extracted from patient's blood after centrifuging

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Fakhreldin Hassan Abdel-Rahman

assistant professor of oral and maxillofacial surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

faculty of dentistry,Mansoura university

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

M18080921

Identifier Type: -

Identifier Source: org_study_id