Evaluation of Locally Delivered Propolis Gels in Periodontitis

NCT06663995 | Active Not Recruiting

• 1 other identifier: FDASU-RecIM122223
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the efficacy of locally delivered propolis gel as an adjunct to scaling and root planning in management of Stage II, Grade B periodontitis . Subjects and Methods I. Patients' selection: Thirty-two (32) patients were recruited from the outpatient clinic of Oral Medicine, Periodontology, and Oral Diagnosis department, Faculty of Dentistry, Ain Shams University. This study was designed as a randomized, controlled, 2-parallel arm, triple blinded, single center clinical trial. Thirty-two eligible patients with stage II and Grade B periodontitis were randomly assigned into 2 groups:

• Group 1 (intervention group) was treated with SRP combined with intrasulcular application of 1% Propolis gel.
• Group 2 (control group) was treated with SRP combined with intrasulcular application of placebo gel.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• Regarding clinical periodontal parameters as a primary objective.

  Probing pocket depth will be measured from the gingival margin to the base of the periodontal pocket to the nearest mm. with use of periodontal probe.

  The following clinical parameters will be recorded for the individuals preoperatively and 3 and 6 months postoperatively.

Secondary Outcomes (1)

• B) Secondary outcome: • Biochemically By analyzing quantitative changes the level of prostaglandin E2 (PGE2) in the gingival crevicular fluid (GCF)

  The examined area will be dried by gentle air stream and isolated with cotton rolls to prevent contamination with saliva. Next, with sterile tweezers one perio paper will be inserted into the selected pocket and left in situ for 30 seconds. Perio paper a

Study Arms (2)

SRP

PLACEBO COMPARATOR

The participants were randomly assigned to receive medicated with SRP combined with intrasulcular application of placebo gel. After baseline assessment, at the same day the included participants will receive full mouth one stage debridement using hand instruments and ultrasonic scalers under local anesthesia -if needed- for patient's comfort. Participants will be provided with a toothpaste, a medium toothbrush, a written oral hygiene instruction brochure (Brushing twice daily for 4-weeks using Modified Bass technique and interdental flossing).

Drug: Control (placebo) group

PROPOLIS group

ACTIVE COMPARATOR

After baseline assessment, at the same day the included participants will receive full mouth one stage debridement using hand instruments and ultrasonic scalers under local anesthesia -if needed- for patient's comfort. 2- Oral Hygiene Instructions Participants will be provided with a toothpaste, a medium toothbrush, a written oral hygiene instruction brochure (Brushing twice daily for 4-weeks using Modified Bass technique and interdental flossing). 3-Base line visit (Local delivery application): Propolis gel will be applied by syringe with blunt tip gently and removed slowly in order not to harm the tissue for group 1 patients (Test group) after phase 1 therapy at the second day (48 hours) following non-surgical periodontal therapy

Drug: Study Group

Interventions

Study Group DRUG

It will include 16 patients with periodontitis stage II, grade B, at least 2 sites with pocket PD = 4-5 mm and CAL = 3-4 mm each will receive non-surgical periodontal therapy followed by application of propolis gel. After baseline assessment, at the same day the included participants will receive full mouth one stage debridement using hand instruments and ultrasonic scalers under local anesthesia -if needed- for patient's comfort. 2- Oral Hygiene Instructions Participants will be provided with a toothpaste, a medium toothbrush, a written oral hygiene instruction brochure (Brushing twice daily for 4-weeks using Modified Bass technique and interdental flossing). 3-Base line visit (Local delivery application): Propolis gel will be applied by syringe with blunt tip gently and removed slowly in order not to harm the tissue for group 1 patients (Test group) after phase 1 therapy at the second day (48 hours) following non-surgical periodontal therapy

PROPOLIS group

Control (placebo) group DRUG

After baseline assessment, at the same day the included participants will receive full mouth one stage debridement using hand instruments and ultrasonic scalers under local anesthesia -if needed- for patient's comfort. 2- Oral Hygiene Instructions Participants will be provided with a toothpaste, a medium toothbrush, a written oral hygiene instruction brochure (Brushing twice daily for 4-weeks using Modified Bass technique and interdental flossing).

SRP

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders aged from 30-50 years 2- Systemically healthy patients as evidenced by (modified Cornell medical index) (Pendleton et al., 2004).
• Patients with Stage II, Grade B Periodontitis, Test sites at least 2 sites have Propping depth (PD)= 4-5 mm or Clinical attachment loss (CAL)= 3-4mm.
• Patient with no history of periodontal therapy or use of antibiotics or anti-inflammatory in the preceding 6 months.
• Patient willing to comply with oral hygiene instructions

You may not qualify if:

• Patients with known allergy to propolis. 2- Smokers or Alcoholics patients. 3- Pregnant and lactating females.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of dentistry Ain Shams University

Cairo, 4393005, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

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: BDS, Clinical demonstrator, oral medicine and periodontology

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 29, 2024
• Study Start: September 17, 2023
• Primary Completion: June 24, 2024
• Study Completion: December 1, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

EG (1)