Assessment Of Healing After Periodontal Flap Surgery With And Without The Use Of Placental Extracts

Summary

All 16 chronic periodontitis (CP) subjects were clinically examined regarding the following clinical periodontal parameters: plaque index (PI), gingival index (GI), bleeding index (BI), Pocket Probing Depth (PPD) and Relative Attachment Loss (RAL) which were recorded for all patients at baseline and 3 months after surgical periodontal treatment.

Pre- surgical procedure:

After the clinical parameters were recorded, Phase I therapy (full mouth scaling, root planning and oral hygiene instructions) was carried out.

The patients were then put under observation to assess the oral hygiene practice and the response of the gingival tissue to Phase I therapy.

After two weeks, patients were recalled and based on further treatment protocol, periodontal flap surgery was planned. Group A (Test Group) underwent periodontal flap surgery during which placental extract was applied. Group B (Control Group) underwent periodontal flap surgery alone.

Surgical procedure The operative sites were anaesthetized with 2% lignocaine hydrochloride with adrenaline (1:180000).

Crevicular incisions were made using Bard Parker No.15 blade on the facial and lingual/palatal surface of each tooth segment or area involved.

A full thickness mucoperiosteal flap was reflected using periosteal elevator taking care to preserve the maximum amount of tissue in the flap. After exposure the granulation tissue was removed, the root surfaces were planed and the flap was trimmed of tissue tags to facilitate healing.

The flap was approximated using interrupted sutures (mersilk 3-0) and a periodontal dressing was placed above it.

Local delivery of the placental extract In group A patients (test group) after open flap debridement 1ml of human placental extracts gel (Placentrex - the original research product of Albert David Limited, India, a drug obtained from fresh term healthy human placentae) was dispensed in a dappen dish.

Gelatin foam (Abgel, Sri Gopal Krishna Labs, Pvt.Ltd. India) was cut into small beads of 1 sq.mm and allowed to soak in the placental gel for a few seconds. These gelatin beads soaked in gel are placed into the surgical site locally with the help of a graft carrier and condensed into the defect area.

To prevent uncontrolled spill-over effects of the gel, mild pressure was applied over the flap with the wet gauze and excess gel was removed and Coe Pak was placed.

While in group B(control group), after open flap debridement, this step is omitted.

Post-operative care Antibiotics and analgesics are prescribed two times a day for five days. Patients were instructed to refrain from chewing hard or sticky foods, brushing near the treated areas or using any interdental aids for 1 week.

The use of mouthwash was avoided during the observation period. All patients were placed on a strict maintenance schedule following surgery. The sutures were removed 10 days later.

Recall appointments were scheduled once in 10 days for the 1st month. At every recall appointment, oral hygiene was checked.

At 3rd month, the clinical parameters were recorded in both the groups. The difference between pre and post-operative values was assessed and then statistically analysed

Conditions

• Periodontal Diseases
• Periodontal Pocket
• Periodontitis

Interventions

BIOLOGICAL

delivery of placentrex gel after open flap debridement

placentrex gel is placed after open flap debridement only in the test group

PROCEDURE

Open Flap Debridement

Open Flap Debridement done in both test and control groups

Sponsors & Collaborators

• Dr Prabhuji MLV

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-04

Primary Completion

2022-08-14

Completion

2023-01-13

Countries

• India

Study Locations