Ignite Creation Date:
2024-05-06 @ 7:13 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05936450
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2023-02-06
Brief Title:
Assessment Of Healing After Periodontal Flap Surgery With And Without The Use Of Placental Extracts
Sponsor:
Dr Prabhuji MLV
Organization:
Krishnadevaraya College of Dental Sciences Hospital
Study Overview
Official Title:
Assessment Of Healing After Periodontal Flap Surgery Using Periostin Levels In Gingival Crevicular Fluid With And Without The Use Of Placental Extracts
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1180000
Crevicular incisions were made using Bard Parker No15 blade on the facial and lingualpalatal 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 PvtLtd India was cut into small beads of 1 sqmm 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 Bcontrol 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
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 1180000
Crevicular incisions were made using Bard Parker No15 blade on the facial and lingualpalatal 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 PvtLtd India was cut into small beads of 1 sqmm 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 Bcontrol 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 FluidGCF 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 stripORAFLOW 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 100µl 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 GENXBIOTM as per the manufacturers 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 1180000
Crevicular incisions were made using Bard Parker No15 blade on the facial and lingualpalatal 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 PvtLtd India was cut into small beads of 1 sqmm 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 Bcontrol 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
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 FluidGCF 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 stripORAFLOW 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 100µl 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 GENXBIOTM as per the manufacturers 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 1180000
Crevicular incisions were made using Bard Parker No15 blade on the facial and lingualpalatal 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 PvtLtd India was cut into small beads of 1 sqmm 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 Bcontrol 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None