PeriodontitisPhase 1NCT04375618
RhEGF Incorporated in An Absorbable Collagen Membrane for The Management Of Gingival Recession Defects
A Phase 1 study testing RhEGF and Plain Collagen in people with Periodontitis, run by SVS Institute of Dental Sciences at 1 site in India.
Trial summary
A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession… Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- RhEGF and Plain Collagen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2019to Nov 2021
- Phase
- Phase 1
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy male and female patients of age 20-55 yrs with Millers class I or class II gingival recession are included in the study.
Who cannot join
- Patients who are medically compromised and Subjects who underwent radiotherapy or chemotherapy and who are Smokers are excluded from the study
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
R V Chandra
Hyderabad, Telangana, 509002
R V Chandra, MDS;DNB;PhD, 9908183071, viswachandra@hotmail.com
About this study
Official title: Efficacy of Recombinant Human Epidermal Growth Factor (RhEGF) Incorporated in An Absorbable Collagen Membrane for The Management of Gingival Recession Defects
A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.
Read the detailed description
IN TEST SITE :
Local anesthesia will be administered and Vertical incisions will be given at interdental papillae away from recession defect site and a pouch will be created. A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.
IN CONTROL SITE:
Same procedure will be done as the test site but plain collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.
- Conditions
- Periodontitis
- Being tested
- RhEGF, Plain Collagen
- Keywords
- epidermal growth factor, gingival recession
- Medical subject headings
- Periodontitis, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhEGFDrug
Also called EGF+Collagen
The EGF impregnated membrane will be placed upon the recession site and will be stabilized by suturing it to the lingual papillae using 4-0 absorbable sutures. The flap will be coronally advanced as far as possible to cover the membrane and will be sutured to the buccal interdental papillae with 4-0 absorbable sutures (Trulenetm, Healthium Medtech Pvt Ltd, Bangalore, India). Standard recall and maintenance regimen will be followed and subjects will be encouraged to report to the department on a monthly basis.
Plain CollagenDrug
Also called Control group
A collagen membrane without FGF-2 will be used.
| Study group | Role | What they receive |
|---|---|---|
| EGF impregnated in collagen membrane | Experimental | EGF impregnated in collagen membrane is placed in gingival recession defects Receives: Drug: RhEGF |
| plain collagen membrane | Active comparator | plain collagen membrane is placed in gingival recession defects Receives: Drug: Plain Collagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession depth (RD)
Recession depth (RD) - measured from cementoenamel junction to most apical extension of gingival margin.
Measured: Base line to 6months.
Secondary outcomes (1)
Width of keratinized gingiva (KGW)
Width of keratinized gingiva (KGW) - distance between gingival margin and mucogingival junction will be evaluated.
Measured: Base line to 6months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Oct 2019
- Primary completionOct 2020 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SVS Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr R Viswa Chandra, SVS Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375618
- Sponsor's protocol ID
- SVSIDS/perio/5/2019
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Recombinant Human Epidermal Growth Factor (RhEGF) Incorporated in An Absorbable Collagen Membrane for The Management of Gingival Recession Defects
- ClinicalTrials.gov ID
- NCT04375618
- Acronym / sponsor ID
- SVSIDS/perio/5/2019
- Conditions
- Periodontitis
- Keywords
- epidermal growth factor, gingival recession
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SVS Institute of Dental SciencesUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 5 May 2020 (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.
A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.
Detailed description
IN TEST SITE :
Local anesthesia will be administered and Vertical incisions will be given at interdental papillae away from recession defect site and a pouch will be created. A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.
IN CONTROL SITE:
Same procedure will be done as the test site but plain collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGF impregnated in collagen membrane | Experimental | Drug: RhEGFEGF impregnated in collagen membrane is placed in gingival recession defects |
| plain collagen membrane | Active comparator | Drug: Plain Collagenplain collagen membrane is placed in gingival recession defects |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemically healthy male and female patients of age 20-55 yrs with Millers class I or class II gingival recession are included in the study.
Key exclusion criteria (1 listed)
- Patients who are medically compromised and Subjects who underwent radiotherapy or chemotherapy and who are Smokers are excluded from the study
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 |
|---|---|---|
| RhEGFAlso: EGF+CollagenThe EGF impregnated membrane will be placed upon the recession site and will be stabilized by suturing it to the lingual papillae using 4-0 absorbable sutures. The flap will be coronally advanced as far as possible to cover the membrane and will be sutured to the buccal interdental papillae with 4-0 absorbable sutures (Trulenetm, Healthium Medtech Pvt Ltd, Bangalore, India). Standard recall and maintenance regimen will be followed and subjects will be encouraged to report to the department on a monthly basis. | Drug | EGF impregnated in collagen membrane |
| Plain CollagenAlso: Control groupA collagen membrane without FGF-2 will be used. | Drug | plain collagen membrane |
Primary outcome
Recession depth (RD)
Time frame: Base line to 6months.
Recession depth (RD) - measured from cementoenamel junction to most apical extension of gingival margin.
1 secondary outcome
Width of keratinized gingiva (KGW)
Time frame: Base line to 6months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RhEGF and Plain Collagen in people with Periodontitis, run by SVS Institute of Dental Sciences 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 1 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: status not confirmed, as of the sponsor's last update on 5 May 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact R V Chandra, MDS;DNB;PHD (9908183071, viswachandra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recession depth (RD) (time frame: Base line to 6months.). 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 5 May 2020.