Periodontal DiseasesPhase 4NCT05936450
Assessment Of Healing After Periodontal Flap Surgery With And Without The Use Of Placental Extracts
A Phase 4 study testing delivery of placentrex gel after open flap debridement and Open Flap Debridement in people with Periodontal Diseases and Periodontal Pocket, run by Dr Prabhuji MLV at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Periodontal Diseases, Periodontal Pocket, Periodontitis
- What is being tested?
- delivery of placentrex gel after open flap debridement and Open Flap Debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIndia
- Study dates
- 4 Mar 2021to 13 Jan 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between the age group of 25 to 55 years.
- Patients with chronic periodontitis, with probing pocket depth (PPD) ≥ 6mm and presence of alveolar defect.
- Systemically healthy subjects.
- Patients who are compliant.
- Patients who had not received any periodontal treatment in the last six months and anti-microbial therapy in past three months.
Who cannot join
- Pregnant and Lactating females.
- Aggressive periodontitis.
- Presence of pulpal or periapical involvement.
- Patients with known conditions precluding any elective surgery.
- Smokers.
- Teeth with poor prognosis.
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157
About this study
Official title: Assessment Of Healing After Periodontal Flap Surgery Using Periostin Levels In Gingival Crevicular Fluid With And Without The Use Of Placental Extracts
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:
Read more
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
Read the 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.
- Conditions
- Periodontal Diseases, Periodontal Pocket, Periodontitis
- Being tested
- delivery of placentrex gel after open flap debridement, Open Flap Debridement
- Keywords
- placental extract, periostin, healing
- Medical subject headings
- Periodontal Diseases, Periodontal Pocket, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delivery of placentrex gel after open flap debridementBiological
placentrex gel is placed after open flap debridement only in the test group
Open Flap DebridementProcedure or surgery
Open Flap Debridement done in both test and control groups
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | placentrex gel + Open Flap Debridement Receives: Biological: delivery of placentrex gel after open flap debridement; Procedure: Open Flap Debridement |
| control group | Active comparator | Open Flap Debridement alone Receives: Procedure: Open Flap Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket Probing Depth (PPD)
Measurements were taken from stent to deepest probing depth to record Probing pocket depth (PPD)
Measured: Change from Baseline Periodontal disease at 3 months
Relative Attachment Loss (RAL)
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.
Measured: Change from Baseline Periodontal disease at 3 months
Plaque Index (PI)
The scoring is done on the entire dentition or on selected teeth. Plaque of the cervical third of the tooth is evaluated with no attention to plaque that has extended to the middle or incisal thirds. The surfaces examined are the four gingival areas of the tooth i.e. the disto-facial, facial, mesio-facial, and lingual surfaces.
Scoring criteria:
0 No plaque
- A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be in situ only after application of disclosing solution or by using probe on the tooth surface.
- Moderate accumulation of soft deposit within the gingival pocket, or the tooth and the gingival margin which can be seen with naked eye.
- Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: Change from Baseline Periodontal disease at 3 months
Gingival Index (GI)
The severity of gingivitis is scored on the mesiofacial and distofacial papillae, facial and lingual margin of selected teeth.A blunt instrument is used to assess the bleeding potential of tissues.The index relies entirely on visual criteria of gingivitis and eliminates the use of probing or pressure to establish the presence or absence of bleeding.
Score Criteria 0 Absence of inflammation/normal gingiva
- Mild inflammation, slight change in color, slight edema; no bleeding on probing
- Moderate inflammation; moderate glazing, redness, edema and hypertrophy. Bleeding on probing.
- Severe inflammation; marked redness, hypertrophy and ulceration. Tendency to spontaneous bleeding
- G.I SCORE = Total score / No of teeth examined
Rating Score Mild gingivitis=0.1-1.0 Moderate gingivitis=1.1-2.0 Severe gingivitis =2.1-3.0
Measured: Change from Baseline Periodontal disease at 3 months
Bleeding Index (BI)
The gingival bleeding index of Ainamo J and Bay I was developed as an easy and suitable way for assessing a patient's progress in Plaque control. The presence or absence of gingival bleeding is determined by gentle probing of the gingival crevice with a periodontal probe. The appearance of bleeding within 10 seconds indicates a positive score, which is expressed as percentage of the total number of gingival margin examined.
- Scoring criteria: Score Criteria 0 No bleeding present on probing within 10 seconds
1 Bleeding present on probing within 10 seconds.
- Calculation : = Total score / No of teeth examined
Measured: Change from Baseline Periodontal disease at 3 months
periostin levels
Collection of gingival crevicular fluid 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.
Measured: Change from Baseline Periodontal disease at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start4 Mar 2021
- Primary completion14 Aug 2022
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Prabhuji MLV
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936450
- Sponsor's protocol ID
- 02_D012_112276
- Status last verified
- Jun 2023
- First submitted
- 6 Feb 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26202398Sharma 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Healing After Periodontal Flap Surgery Using Periostin Levels In Gingival Crevicular Fluid With And Without The Use Of Placental Extracts
- ClinicalTrials.gov ID
- NCT05936450
- Acronym / sponsor ID
- 02_D012_112276
- Conditions
- Periodontal Diseases, Periodontal Pocket, Periodontitis
- Keywords
- placental extract, periostin, healing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Dr Prabhuji MLVUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Biological: delivery of placentrex gel after open flap debridement, Procedure: Open Flap Debridementplacentrex gel + Open Flap Debridement |
| control group | Active comparator | Procedure: Open Flap DebridementOpen Flap Debridement alone |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients between the age group of 25 to 55 years.
- Patients with chronic periodontitis, with probing pocket depth (PPD) ≥ 6mm and presence of alveolar defect.
- Systemically healthy subjects.
- Patients who are compliant.
- Patients who had not received any periodontal treatment in the last six months and anti-microbial therapy in past three months.
Key exclusion criteria (6 listed)
- Pregnant and Lactating females.
- Aggressive periodontitis.
- Presence of pulpal or periapical involvement.
- Patients with known conditions precluding any elective surgery.
- Smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| delivery of placentrex gel after open flap debridementplacentrex gel is placed after open flap debridement only in the test group | Biological | test group |
| Open Flap DebridementOpen Flap Debridement done in both test and control groups | Procedure or surgery | control group, test group |
Primary outcome
Pocket Probing Depth (PPD)
Time frame: Change from Baseline Periodontal disease at 3 months
Measurements were taken from stent to deepest probing depth to record Probing pocket depth (PPD)
Relative Attachment Loss (RAL)
Time frame: Change from Baseline Periodontal disease at 3 months
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.
Plaque Index (PI)
Time frame: Change from Baseline Periodontal disease at 3 months
The scoring is done on the entire dentition or on selected teeth. Plaque of the cervical third of the tooth is evaluated with no attention to plaque that has extended to the middle or incisal thirds. The surfaces examined are the four gingival areas of the tooth i.e. the disto-facial, facial, mesio-facial, and lingual surfaces. Scoring criteria: 0 No plaque 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be in situ only after application of disclosing solution or by using probe on the tooth surface. 2. Moderate accumulation of soft deposit within the gingival pocket, or the tooth and the gingival margin which can be seen with naked eye. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Gingival Index (GI)
Time frame: Change from Baseline Periodontal disease at 3 months
The severity of gingivitis is scored on the mesiofacial and distofacial papillae, facial and lingual margin of selected teeth.A blunt instrument is used to assess the bleeding potential of tissues.The index relies entirely on visual criteria of gingivitis and eliminates the use of probing or pressure to establish the presence or absence of bleeding. Score Criteria 0 Absence of inflammation/normal gingiva 1. Mild inflammation, slight change in color, slight edema; no bleeding on probing 2. Moderate inflammation; moderate glazing, redness, edema and hypertrophy. Bleeding on probing. 3. Severe inflammation; marked redness, hypertrophy and ulceration. Tendency to spontaneous bleeding * G.I SCORE = Total score / No of teeth examined Rating Score Mild gingivitis=0.1-1.0 Moderate gingivitis=1.1-2.0 Severe gingivitis =2.1-3.0
Bleeding Index (BI)
Time frame: Change from Baseline Periodontal disease at 3 months
The gingival bleeding index of Ainamo J and Bay I was developed as an easy and suitable way for assessing a patient's progress in Plaque control. The presence or absence of gingival bleeding is determined by gentle probing of the gingival crevice with a periodontal probe. The appearance of bleeding within 10 seconds indicates a positive score, which is expressed as percentage of the total number of gingival margin examined. • Scoring criteria: Score Criteria 0 No bleeding present on probing within 10 seconds 1 Bleeding present on probing within 10 seconds. • Calculation : = Total score / No of teeth examined
periostin levels
Time frame: Change from Baseline Periodontal disease at 3 months
Collection of gingival crevicular fluid 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Background: PubMed 26202398Padial-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.
- BackgroundSharma 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.
Related trials for Periodontal Diseases
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing delivery of placentrex gel after open flap debridement and Open Flap Debridement in people with Periodontal Diseases and Periodontal Pocket, run by Dr Prabhuji MLV at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket Probing Depth (PPD) (time frame: Change from Baseline Periodontal disease at 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05936450, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.