PeriodontitisNCT04772508
Effect of Amnion Membrane With and Without Taurine on GCF TNF α Level.
A study testing Scaling and root planing, Amnion membrane and Taurine in people with Periodontitis, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
Trial summary
45 sites in 15 patients with periodontal pockets ≥ 5mm were selected. These selected sites were divided into 3 groups as Group A, B and C. Read more about this study
- Who is it for?
- Ages 29 to 60 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Scaling and root planing, Amnion membrane and Taurine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2020to 13 Mar 2021
- Phase
- Interventional
- 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 29 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- •Systemically healthy patients with sites showing probing depth (PD) ≥ 5mm, clinical attachment level (CAL) ≥ 4 mm, and vertical bone loss ≥ 3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months
Who cannot join
- Any systemic disease that could influence the outcome of periodontal therapy.
- Smokers, alcoholics \& patients with other adverse habits.
- Pregnant or nursing women.
- Any known allergy or hypersensitivity to any product used in the study.
- Patients on long term systemic therapy (antibiotics, anti-inflammatory and any other).
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Periodontology, M.M. College of Dental Sciences and Research.
Ambāla, Haryana, 133207
About this study
Official title: Efficacy of Subgingivally Placed Amnion Membrane With and Without Taurine as an Adjunct to Scaling and Root Planing in the Treatment of Chronic Periodontitis
45 sites in 15 patients with periodontal pockets ≥ 5mm were selected. These selected sites were divided into 3 groups as Group A, B and C.
Read the detailed description
Group A (Control): 15 sites received only SRP, Group B: 15 sites received SRP with subgingival placement of amnion membrane, Group C: 15 sites received SRP with subgingival placement of Amnion membrane hydrated with Taurine.
- Conditions
- Periodontitis
- Being tested
- Scaling and root planing, Amnion membrane, Taurine
- Keywords
- periodontitis, taurine, amnion membrane
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Also called SRP
15 sites with periodontal pockets ≥ 5mm received only SRP
Amnion membraneBiological
Also called AM
15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane.
TaurineDrug
Also called T
15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane hydrated with taurine.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Sham comparator | 15 sites received only scaling and root planing Receives: Procedure: Scaling and root planing |
| Group B | Active comparator | 15 sites received scaling and root planing with subgingival placement of amnion membrane Receives: Procedure: Scaling and root planing; Biological: Amnion membrane |
| Group C | Active comparator | 15 sites received scaling and root planing with subgingival placement of amnion membrane hydrated with Taurine Receives: Procedure: Scaling and root planing; Biological: Amnion membrane; Drug: Taurine |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNF-α level
TNF-α level in Gingival crevicular fluid
Measured: changes from baseline to 45 days
Probing pocket depth (PPD)
Probing pocket depth at selected site
Measured: changes from baseline to 45 days
Relative attachment level (RAL)
Relative attachment level from stent to base of the pocket
Measured: changes from baseline to 45 days
Secondary outcomes (3)
Plaque index (PI)
Plaque index (PI) - Silness and Loe 1964 site specific
Measured: changes from baseline to 45 days
Gingival index (GI)
Gingival index (GI) - Loe and Silness 1963 site specific
Measured: changes from baseline to 45 days
Bleeding on probing (BOP)
Bleeding on probing (BOP): Muhlemann HR \& Son 1971 sit specific
Measured: changes from baseline to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Dec 2020
- Primary completion13 Mar 2021
- Study completion13 Mar 2021
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 PeriodontitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A (Control): 15 sites received only SRP, Group B: 15 sites received SRP with subgingival placement of amnion membrane, Group C: 15 sites received SRP with subgingival placement of Amnion membrane hydrated with Taurine.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR SURINDER SACHDEVA, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- surinder sachdeva, M.D.S., Study director, PROFESSOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772508
- Sponsor's protocol ID
- 13/395
- Status last verified
- Mar 2021
- First submitted
- 23 Feb 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giris M, Depboylu B, Dogru-Abbasoglu S, Erbil Y, Olgac V, Alis H, Aykac-Toker G, Uysal M. Effect of taurine on oxidative stress and apoptosis-related protein expression in trinitrobenzene sulphonic acid-induced colitis. Clin Exp Immunol. 2008 Apr;152(1):102-10. doi: 10.1111/j.1365-2249.2008.03599.x. Epub 2008 Jan 28.
PubMed 18241224Gultekin SE, Senguven B, Sofuoglu A, Taner L, Koch M. Effect of the topical use of the antioxidant taurine on the two basement membrane proteins of regenerating oral gingival epithelium. J Periodontol. 2012 Jan;83(1):127-34. doi: 10.1902/jop.2011.100568. Epub 2011 May 16.
PubMed 21574832
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Subgingivally Placed Amnion Membrane With and Without Taurine as an Adjunct to Scaling and Root Planing in the Treatment of Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT04772508
- Acronym / sponsor ID
- 13/395
- Conditions
- Periodontitis
- Keywords
- periodontitis, taurine, amnion membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 13 Mar 2021 (actual)
- Study completion
- 13 Mar 2021 (actual)
- First posted
- 26 Feb 2021 (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.
45 sites in 15 patients with periodontal pockets ≥ 5mm were selected. These selected sites were divided into 3 groups as Group A, B and C.
Detailed description
Group A (Control): 15 sites received only SRP, Group B: 15 sites received SRP with subgingival placement of amnion membrane, Group C: 15 sites received SRP with subgingival placement of Amnion membrane hydrated with Taurine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Group A (Control): 15 sites received only SRP, Group B: 15 sites received SRP with subgingival placement of amnion membrane, Group C: 15 sites received SRP with subgingival placement of Amnion membrane hydrated with Taurine.
| Arm | Type | Receives |
|---|---|---|
| Group A | Sham comparator | Procedure: Scaling and root planing15 sites received only scaling and root planing |
| Group B | Active comparator | Procedure: Scaling and root planing, Biological: Amnion membrane15 sites received scaling and root planing with subgingival placement of amnion membrane |
| Group C | Active comparator | Procedure: Scaling and root planing, Biological: Amnion membrane, Drug: Taurine15 sites received scaling and root planing with subgingival placement of amnion membrane hydrated with Taurine |
Who may qualify
- Ages
- 29 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- •Systemically healthy patients with sites showing probing depth (PD) ≥ 5mm, clinical attachment level (CAL) ≥ 4 mm, and vertical bone loss ≥ 3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months
Key exclusion criteria (5 listed)
- Any systemic disease that could influence the outcome of periodontal therapy.
- Smokers, alcoholics \& patients with other adverse habits.
- Pregnant or nursing women.
- Any known allergy or hypersensitivity to any product used in the study.
- Patients on long term systemic therapy (antibiotics, anti-inflammatory and any other).
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 |
|---|---|---|
| Scaling and root planingAlso: SRP15 sites with periodontal pockets ≥ 5mm received only SRP | Procedure or surgery | Group A, Group B, Group C |
| Amnion membraneAlso: AM15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane. | Biological | Group B, Group C |
| TaurineAlso: T15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane hydrated with taurine. | Drug | Group C |
Primary outcome
TNF-α level
Time frame: changes from baseline to 45 days
TNF-α level in Gingival crevicular fluid
Probing pocket depth (PPD)
Time frame: changes from baseline to 45 days
Probing pocket depth at selected site
Relative attachment level (RAL)
Time frame: changes from baseline to 45 days
Relative attachment level from stent to base of the pocket
3 secondary outcomes
Plaque index (PI)
Time frame: changes from baseline to 45 days
Gingival index (GI)
Time frame: changes from baseline to 45 days
Bleeding on probing (BOP)
Time frame: changes from baseline to 45 days
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 16 Mar 2021.
- Background: PubMed 18241224Giris M, Depboylu B, Dogru-Abbasoglu S, Erbil Y, Olgac V, Alis H, Aykac-Toker G, Uysal M. Effect of taurine on oxidative stress and apoptosis-related protein expression in trinitrobenzene sulphonic acid-induced colitis. Clin Exp Immunol. 2008 Apr;152(1):102-10. doi: 10.1111/j.1365-2249.2008.03599.x. Epub 2008 Jan 28.
- Background: PubMed 21574832Gultekin SE, Senguven B, Sofuoglu A, Taner L, Koch M. Effect of the topical use of the antioxidant taurine on the two basement membrane proteins of regenerating oral gingival epithelium. J Periodontol. 2012 Jan;83(1):127-34. doi: 10.1902/jop.2011.100568. Epub 2011 May 16.
- Individual participant dataSharing planned: No
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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.
surinder sachdeva, M.D.S. study director
PROFESSOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing, Amnion membrane and Taurine in people with Periodontitis, run by Maharishi Markendeswar University (Deemed to be University) 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 1 inclusion and 5 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 16 Mar 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
TNF-α level (time frame: changes from baseline to 45 days). The study lists 3 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 NCT04772508, 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 16 Mar 2021.