Clinical trial NCT05936450: Assessment Of Healing After Periodontal Flap Surgery With And Without The Use Of Placental Extracts
Official title: Assessment Of Healing After Periodontal Flap Surgery Using Periostin Levels In Gingival Crevicular Fluid With And Without The Use Of Placental Extracts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontal Diseases
Periodontal Pocket
Periodontitis
Keywords: placental extract
periostin
healing
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patients between the age group of 25 to 55 years.
2. Patients with chronic periodontitis, with probing pocket depth (PPD) ≥ 6mm and presence of alveolar defect.
3. Systemically healthy subjects.
4. Patients who are compliant.
5. Patients who had not received any periodontal treatment in the last six months and anti-microbial therapy in past three months.

Exclusion Criteria:

1. Pregnant and Lactating females.
2. Aggressive periodontitis.
3. Presence of pulpal or periapical involvement.
4. Patients with known conditions precluding any elective surgery.
5. Smokers.
6. Teeth with poor prognosis.

Primary outcomes:
measure: Pocket Probing Depth (PPD)
timeFrame: Change from Baseline Periodontal disease at 3 months
measure: Relative Attachment Loss (RAL)
timeFrame: Change from Baseline Periodontal disease at 3 months
measure: Plaque Index (PI)
timeFrame: Change from Baseline Periodontal disease at 3 months
measure: Gingival Index (GI)
timeFrame: Change from Baseline Periodontal disease at 3 months
measure: Bleeding Index (BI)
timeFrame: Change from Baseline Periodontal disease at 3 months
measure: periostin levels
timeFrame: Change from Baseline Periodontal disease at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya college of dental sciences
state: Karnataka
Study officials:
References:
citation: Padial-Molina M, Volk SL, Rios HF. Preliminary insight into the periostin leverage during periodontal tissue healing. J Clin Periodontol. 2015 Aug;42(8):764-772. doi: 10.1111/jcpe.12432. Epub 2015 Aug 19.
citation: Sharma A, Sharma S, Nagar A. Comparative Evaluation to Assess the Effect of SRP With or Without Human Placental Extracts as Local Drug Delivery in Treatment of Localized Periodontal Pocket-A Randomized Controlled Clinical Trial.