Placenta Extract Gel as a Periodontal Local Delivery Drug
NCT Number: NCT06506539
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Periodontal Pocket|Periodontitis
Interventions: DRUG: Placental Extract
Sponsor: Suez Canal University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-04-01
Completion Date: 2022-03-01
Locations: Suez Canal University, Ismailia, Egypt

Summary:
Introduction: Periodontal disease is one of the most prevalent global chronic disorders. Pathology affecting the structure surrounding teeth results in inflammation initiated by bacterial aggregation and alteration in their profile.

conventional periodontal therapeutics has focused on the control of etiologic agents, thereby promoting healing, repair of tissues delivery of therapeutic agents into the pocket act as drug reservoirs which could alter pathogenic flora and promote its repair and wound healing. Aim of the study: Evaluate the effect of locally delivered placenta extract gel as an adjunct to scaling and root planning in the treatment of periodontal pocket. Methodology: 30 patients with grade B stage II periodontitis will be selected from the Faculty of Dentistry Suez Canal University outpatient clinic and divided into 2 equal groups. Group I: will have scaling and root planning.

Group II: will have scaling and root planning with placenta extract gel locally delivered in the periodontal pocket. All clinical parameters (plaque index, gingival index, probing pocket depth, and clinical attachment) and lab investigations (vascular endothelial growth factor and fibroblast growth factor) will be measured at 0,1 and 3 months. All results will be tabulated and statistically analyzed using the SPSS program.

Primary Outcome Measures: plaque index (PI), PI was used to determine the amount of plaque on the tooth surface

To determine the plaque index, Silness \& Löe reference values were taken as a basis:

Plaque index 0: No plaque is in the area adjacent to the gingiva. Plaque index 1: There is a plaque in the form of a thin film on the gingival margin.

Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin.

Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin., 3 months|gingival index (GI), o determine the gingival index of the patients, gingival bleeding caused by running a Williams periodontal probe inside the pocket on the mesial, distal, buccal, and palatal surfaces of all teeth was evaluated. The gingival index of an individual was obtained by summing the values determined for each tooth and calculating the averages. To determine the gingival index, Löe \& Silness reference values were taken as a basis: Gingival index 0: Healthy gums. Gingival index 1: Mild discolouration and oedematous gingiva. No bleeding on probing.

Gingival index 2: Red, oedematous and shiny gingiva. There is bleeding on probing.

Gingival index 3: Red, oedematous, and ulcerated gingiva. There is spontaneous bleeding., 3 months|probing pocket depth (PD), Measured from the free gingival margin to the bottom of the pocket with an unc 15 periodontal probe, 3 months|clinical attachment level(CAL)., The distance from CEJ to the bottom of the pocket. It was measured in the same way described for probing depth.

CAL was recorded by subtracting the length of the deepest probing depth from the stent by the length from the stent to the cemento-enamel junction., 3 months
Secondary Outcome Measures: Vascular endothelial growth factor (VEGF), recorded in picograms per milliliter (pg/mL), 3 months|fibroblast growth factor (FGF), recorded in picograms per milliliter (pg/mL), 3 months