Efficacy of Injectable Platelet-rich Fibrin Versus Platelet-Rich Plasma As Adjunctive to Scaling and Root Planning in Non-surgical Periodontal Therapy of Periodontitis Patients

NCT06685393 | Completed

• 1 other identifier: A11060722
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the Efficacy of Injectable Platelet-rich Fibrin versus Platelet-Rich Plasma as adjunctive to scaling and root planning in non-surgical periodontal therapy of Periodontitis patients (Randomized controlled clinical trial)

Conditions

Peridontal Disease

Keywords

periodontitis, PRP, I-PRF

Outcome Measures

Primary Outcomes (4)

• clinical measurement of plaque index (PI).

  It assesses oral hygiene and is based on the recording of soft debris on the teeth, plaque was scored using the plaque indices the Tarski et al Modified Quigley Hein Plaque Index (TQHPI). With the TQHPI, mesial, distal, and mid surfaces of facial and lingual aspects were scored: 0 = no plaque/debris 1. = separate flecks of plaque at the cervical margin of the tooth. 2. = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth. 3. = a band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth. 4. = plaque covering at least one-third but less than two-thirds of the crown of the tooth. 5. = plaque covering two-thirds or more of the crown of the tooth. The index for the tooth was calculated by adding the scores from the six surfaces of the tooth and dividing them by six. For each patient, a plaque index was calculated by adding up the indices for each of the teeth examined and dividing by the number of these teeth.

  3 months

• clinical measurement of sulcular bleeding index (SBI).

  In 1971, Muhlemann \& Son introduced the SBI, which was defined as follows: Score 0 gingiva of normal texture and color, no bleeding. Score 1: gingiva normal, bleeding on probing. Score 2: bleeding on probing, change in color, no edema. Score 3: bleeding on probing change in color, slight oedema. Score 4: either: (a) bleeding on probing, change in color, obvious edema or (b) bleeding on probing, obvious edema. Score 5: bleeding on probing and spontaneous bleeding, change in color, marked edema.

  3 months

• clinical measurement of Probing depth (PD).

  For all groups, the pocket depth measurement was calculated from the gingival margin to the base of the pocket in each quadrant between the first premolar and 1ST molar. It was taken at 6 locations which were mesiofacial, midfacial, distofacial, mesiolingual, midlingual, and distolingual. To the closest millimeter, the standard William's graded probe was employed. It was inserted parallel to the tooth's long axis with light force; if present, any heavy calculus deposits interfering with measurement were removed. The measurements were put together before being divided by six to determine the mean value of every tooth. Following that, the pocket depth value for each patient was calculated by summing the values of all teeth, and then the total number of teeth tested divided by the sum.

  3 months

• clinical measurement of Clinical attachment level (CAL).

  For all groups, in each quadrant CAL is measured from the first premolar to the 2nd molar(in mm). By recording six values for every tooth and dividing them by six, the mean value for each tooth was determined. Then, by dividing the total number of teeth inspected by the sum of teeth, we got the mean value of CAL for each patient. If the CEJ landmark is missing because it has been destroyed by dental caries or has been removed by placement of a dental restoration, another fixed reference point can be used to measure attachment loss. Such landmarks might include the apical margin of a restoration or the incisal edge of a tooth. When attachment loss measurements are taken from a fixed landmark other than the CEJ they are called relative attachment loss measurements. Clinical attachment loss or relative attachment loss measurements are the best way to assess the presence or absence of additional periodontal damage

  3 months

Secondary Outcomes (1)

• MICROBIOLOGICAL PARAMETERS

  3 months

Study Arms (4)

Group (I) (nondiabetic PRPgroup)

ACTIVE COMPARATOR

Group (Ⅰ) (non-diabetic patients): n=10 subdivided into Test side: received scaling and rootplanning plus the subgingival application of PRP. Control side: received scaling and rootplanning only.

Procedure: Platelet rich plasma (PRP)

Group (Ⅱ) (non-diabetic patients):

ACTIVE COMPARATOR

Group (Ⅱ) (non-diabetic patients): n=10 subdivided into Test side: received MD plus subgingival application of I-PRF. Control side: received MD only.

Procedure: INJECTABLE PLATELET RICH FIBRIN(I-PRF)

Group (Ⅲ) (diabetic patients)

ACTIVE COMPARATOR

Group (Ⅲ) (diabetic patients): n=10 subdivided into Test side: received MD plus subgingival application of PRP. Control side: received MD only.

Procedure: Platelet rich plasma (PRP)

Group(Ⅳ) (diabetic patients)

ACTIVE COMPARATOR

Group(Ⅳ) (diabetic patients): n=10 subdivided into Test side: received MD plus the subgingival application of I-PRF Control side: received MD only.

Procedure: INJECTABLE PLATELET RICH FIBRIN(I-PRF)

Interventions

Platelet rich plasma (PRP) PROCEDURE

At the 1st visit, each quadrant is scaled and root planned using an ultrasonic scaler and manual instruments until tactile sensation detects smooth crown and root surfaces these procedures were repeated on both sides starting from 1st visit of treatment,2nd,4th, and 6th-week intervals local anesthetic was utilized in some instances where it was the necessary and subgingival application of (PRP) at test side only at baseline,3ed, 6th week.

Group (I) (nondiabetic PRPgroup); Group (Ⅲ) (diabetic patients)

INJECTABLE PLATELET RICH FIBRIN(I-PRF) PROCEDURE

At the 1st visit, each quadrant is scaled and root planned using an ultrasonic scaler and manual instruments until tactile sensation detects smooth crown and root surfaces these procedures were repeated on both sides starting from 1st visit of treatment,2nd,4th, and 6th-week intervals local anesthetic was utilized in some instances where it was the necessary and subgingival application of (I-PRF) at test side only at baseline,3ed, 6th week.

Group (Ⅱ) (non-diabetic patients):; Group(Ⅳ) (diabetic patients)

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants: Adult healthy individuals between 25-45 years old with no gender predilection diagnosed with periodontitis.
• Fasting blood sugar (80-100mg/dl): This is the recommended range for non-diabetic patients and is according to the American Diabetes Association.
• (Hemoglobin A1C (HbA1c) levels recommended by the American Diabetes Association. Patients with an HbA1c level equal to or less than 7% were considered patients with well-controlled DM.
• Patients with at least two quadrants with pocket depth up to 5 mm.

You may not qualify if:

• history of any preceding oral infections or periodontal treatment for at least three months before starting the study.
• Smokers and alcoholic patients
• pregnant, post-menopausal, and lactating women.
• Patients with poor systemic health like uncontrolled diabetes, hypertension, osteoporosis, and collagen disorders are also excluded with
• patients who were on or expected to take antibiotics or anti-inflammatory drugs within the duration of the study.

Sponsors & Collaborators

• ELsabbahy Ahmed Mohamed Youssef: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia, Egypt, 35516, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Elsabbahy Ahmed Mohamed youssef, B.D.S

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double (participant, outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: B.D.S, Faculty of dentistry, Mansoura University 2001. principal Investigator.

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: January 5, 2023
• Primary Completion: December 20, 2023
• Study Completion: March 25, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-10

Locations

EG (1)