Periodontal Intrabony DefectNCT03638154
Regenerative Potential of Cultured Gingival Fibroblast- Mesenchymal Stem Cells in Treatment of Periodontitis
A study testing GF+GMSCs carried on β TCP and β TCP bone substitute only in people with Periodontal Intrabony Defect, run by Ain Shams University.
Trial summary
clinical trial was conducted to evaluate regenerative potentials of cultured gingival fibroblasts and GMSCs carried in beta tri calcium phosphate scaffold into intrabony periodontal defects in human by clinical and radiographic parameters Read more about this study
- Who is it for?
- Ages 32 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Intrabony Defect
- What is being tested?
- GF+GMSCs carried on β TCP and β TCP bone substitute only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2016to 22 Feb 2018
- 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 32 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of interproximal osseous defects estimated from radiographic evaluation (Cone Beam CT) and transgingival bone sounding ≥3mm of two or three osseous walls.
- Probing Depth ≥5mm after initial therapy.
- Attachment loss ≥4mm.
- full mouth plaque score and bleeding on probing score ≤ 20% after phase I therapy.
- non vital teeth only involved.
- no furcation involvement of the teeth presenting the intraosseous defects.
- Thick gingival biotype more than 1 mm with enough width of attached gingiva.
- Accepts Healthy Volunteers
Who cannot join
- Patients with systemic disease or compromised immune illness using Cornell medical index
- Smoker's patients.
- Pregnant and lactating females.
- Uncooperative patients (low compliance, bad oral hygiene).
- Decision impaired individuals (prisoners, handicapped and mentally retarded patients).
About this study
Official title: Clinical Regenerative Potential of Cultured Gingival Fibroblast- Mesenchymal Stem Cells in Treatment of Periodontal Intrabony Defects (Randomized Clinical and Biochemical Trial)
clinical trial was conducted to evaluate regenerative potentials of cultured gingival fibroblasts and GMSCs carried in beta tri calcium phosphate scaffold into intrabony periodontal defects in human by clinical and radiographic parameters
Read the detailed description
In the present study, twenty posterior two or three osseous intrabony periodontal defects were involved . They were grouped in to two groups. Group I included ten intrabony posterior defect received beta tri calcium phosphate (β TCP) bone substitute. Group II included ten posterior intrabony periodontal defect and they received a mixture of gingival fibroblast(GF) and gingival mesenchymal stem cells(GMSCs) carried on a vehicle of β TCP covered by a resorbable collagen membrane. CBCT was used preoperatively and after 6 months for hard tissue evaluation. PDGF and BMP were measured in GCF at days 1,3,7,14.
- Conditions
- Periodontal Intrabony Defect
- Being tested
- GF+GMSCs carried on β TCP, β TCP bone substitute only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GF+GMSCs carried on β TCPProcedure or surgery
surgical augmentation of GF+GMSCs carried on β TCP in intrabony periodontal defect and covered by collagen membrane(Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) Cytoplast, RTM Collagen Cytoplast, Barrier Membranes, Osteogenics Biomedical, New Gersey, USA).
Ibuprofen
β TCP bone substitute onlyProcedure or surgery
surgical augmentation by β TCP in intrabony periodontal defect(Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) Ibuprofen
| Study group | Role | What they receive |
|---|---|---|
| GroupI | Placebo comparator | safety with received beta-tricalcium phosphate (β TCP) bone substitute only. (Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) Receives: Procedure: β TCP bone substitute only |
| GroupII | Active comparator | safety with surgical augmentation of GF+GMSCs carried on β TCP in intrabony periodontal defect and covered by collagen membrane and received a mixture of gingival fibroblast(GF) and gingival mesenchymal stem cells(GMSCs) carried on a vehicle of β TCP covered by a resorbable collagen membrane.
(Cytoplast, RTM Collagen Cytoplast, Barrier Membranes, Osteogenics Biomedical, New Jersey, USA). Receives: Procedure: GF+GMSCs carried on β TCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone gain in periodontal defects(by mm)
20 patients were involved as assessed by cone beam ct at baseline (pre) and 6 months later(post). the fusion of pre and post operative cone beam ct scan of the intrabony periodontal defect to measure bone gain by mm. so that, the regenerative potentials of cultured gingival into ten intrabony defect fibroblasts and GMSCs carried by tri calcium phosphate , the bone gain was measured by radiographic fusion of pre and post image of intrabony periodontal defects in human.
Measured: 6 months
Secondary outcomes (1)
the regenerative power of the defect was evaluated by growth factor concentration in GCF.
4 GCF samples were collected from each patient at day 1,3,7,14 after periodontal surgery then a Biochemical analysis of BMP-2 and PDGF-bb (by mg /dl) concentrations in GCF by using ELIZA kite which reflect the healing power at the initial periods of healing in different groups.
Measured: day 1,3,7,14 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start15 Mar 2016
- Primary completion15 Apr 2016
- Study completion22 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Intrabony DefectStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahetab mohamed abdel el wahab, Ain Shams University
- Investigators
- Ahmed Gamal, professor, Study director, Professor of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638154
- Sponsor's protocol ID
- PER 16-P1
- Status last verified
- Aug 2018
- First submitted
- 22 Jun 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Regenerative Potential of Cultured Gingival Fibroblast- Mesenchymal Stem Cells in Treatment of Periodontal Intrabony Defects (Randomized Clinical and Biochemical Trial)
- ClinicalTrials.gov ID
- NCT03638154
- Acronym / sponsor ID
- PER 16-P1
- Conditions
- Periodontal Intrabony Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 15 Apr 2016 (actual)
- Study completion
- 22 Feb 2018 (actual)
- First posted
- 20 Aug 2018 (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.
clinical trial was conducted to evaluate regenerative potentials of cultured gingival fibroblasts and GMSCs carried in beta tri calcium phosphate scaffold into intrabony periodontal defects in human by clinical and radiographic parameters
Detailed description
In the present study, twenty posterior two or three osseous intrabony periodontal defects were involved . They were grouped in to two groups. Group I included ten intrabony posterior defect received beta tri calcium phosphate (β TCP) bone substitute. Group II included ten posterior intrabony periodontal defect and they received a mixture of gingival fibroblast(GF) and gingival mesenchymal stem cells(GMSCs) carried on a vehicle of β TCP covered by a resorbable collagen membrane. CBCT was used preoperatively and after 6 months for hard tissue evaluation. PDGF and BMP were measured in GCF at days 1,3,7,14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GroupI | Placebo comparator | Procedure: β TCP bone substitute onlysafety with received beta-tricalcium phosphate (β TCP) bone substitute only. (Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) |
| GroupII | Active comparator | Procedure: GF+GMSCs carried on β TCPsafety with surgical augmentation of GF+GMSCs carried on β TCP in intrabony periodontal defect and covered by collagen membrane and received a mixture of gingival fibroblast(GF) and gingival mesenchymal stem cells(GMSCs) carried on a vehicle of β TCP covered by a resorbable collagen membrane. (Cytoplast, RTM Collagen Cytoplast, Barrier Membranes, Osteogenics Biomedical, New Jersey, USA). |
Who may qualify
- Ages
- 32 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Presence of interproximal osseous defects estimated from radiographic evaluation (Cone Beam CT) and transgingival bone sounding ≥3mm of two or three osseous walls.
- full mouth plaque score and bleeding on probing score ≤ 20% after phase I therapy.
- Accepts Healthy Volunteers
Key exclusion criteria (5 listed)
- Patients with systemic disease or compromised immune illness using Cornell medical index
- Smoker's patients.
- Pregnant and lactating females.
- Uncooperative patients (low compliance, bad oral hygiene).
- Decision impaired individuals (prisoners, handicapped and mentally retarded patients).
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 |
|---|---|---|
| GF+GMSCs carried on β TCPsurgical augmentation of GF+GMSCs carried on β TCP in intrabony periodontal defect and covered by collagen membrane(Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) Cytoplast, RTM Collagen Cytoplast, Barrier Membranes, Osteogenics Biomedical, New Gersey, USA). Ibuprofen | Procedure or surgery | GroupII |
| β TCP bone substitute onlysurgical augmentation by β TCP in intrabony periodontal defect(Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) Ibuprofen | Procedure or surgery | GroupI |
Primary outcome
bone gain in periodontal defects(by mm)
Time frame: 6 months
20 patients were involved as assessed by cone beam ct at baseline (pre) and 6 months later(post). the fusion of pre and post operative cone beam ct scan of the intrabony periodontal defect to measure bone gain by mm. so that, the regenerative potentials of cultured gingival into ten intrabony defect fibroblasts and GMSCs carried by tri calcium phosphate , the bone gain was measured by radiographic fusion of pre and post image of intrabony periodontal defects in human.
1 secondary outcome
the regenerative power of the defect was evaluated by growth factor concentration in GCF.
Time frame: day 1,3,7,14 after surgery
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 20 Aug 2018.
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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.
Ahmed Gamal, professor study director
Professor of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing GF+GMSCs carried on β TCP and β TCP bone substitute only in people with Periodontal Intrabony Defect, run by Ain Shams University.
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 8 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 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
bone gain in periodontal defects(by mm) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2018.