Assessment Of Healing After Periodontal Flap Surgery With And Without The Use Of Placental Extracts
Condition: Periodontal Diseases; Periodontal Pocket; Periodontitis
MeSH terms: Periodontitis; Periodontal Diseases; Periodontal Pocket
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      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.

      Technique to ascertain the Probing Pocket Depth (PPD) and Relative attachment Level (RAL) at
      the treatment sites: A customized acrylic stent was fabricated for each patient for providing
      a reproducible insertion axis for the probe. The stent was grooved in an occluso-apical
      direction for the above mentioned purpose. The following clinical parameters were recorded
      with the help of a Hu Friedy UNC 15 probe.

      Measurements were taken from stent to deepest probing depth to record Probing pocket depth
      (PPD) while Relative Attachment level (RAL) were recorded by subtracting the length of
      deepest probing depth from stent by the length from stent to cemento-enamel junction.

      Collection of Gingival Crevicular Fluid(GCF) GCF samples were obtained from the buccal
      aspects of the selected site. The sites were isolated by cotton rolls, rinsed with water and
      dried with a gentle air spray directed perpendicular to the gingival margin.

      Removal of supra-gingival plaque was completed utilizing dry gauze, and a sterile filter
      paper strip((ORAFLOW). ® was gently inserted into the entrance of the selected site until the
      first sign of resistance was felt for 30 sec. Samples contaminated with gingival bleeding
      were excluded.

      The GCF sample volume will be measured in a calibrated appliance (Periotron 8000 Proflow
      Inc., Amityville, NY, USA) TM, after which the reading will be converted to an actual volume
      (µl) by reference to the standard curve.

      The strips from the selected site will be transferred in micro centrifuged tubes containing
      100(µl) of phosphate buffer saline.

      The samples will be stored at -80 0C till the assay is performed using Enzyme Linked Immuno
      Sorbent Assay (ELISA) kit obtained from (GENXBIO)TM, as per the manufacturer's instructions.

      The same steps are repeated at baseline, 6 weeks and 3 months.

      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 1 ml 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.
    

Intervention name(s): delivery of placentrex gel after open flap debridement; Open Flap Debridement
Intervention type(s): Biological; Procedure
Intervention description(s): placentrex gel is placed after open flap debridement only in the test group; Open Flap Debridement done in both test and control groups
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: placental extract; periostin; healing