Thin-gingivaNCT05449925
Effect Of Injectable PRF And Microneedling In Patient Undergoing Orthodontic Treatment
A study testing Injectable PRF and Microneedling in people with Thin-gingiva, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
To evaluate the effect injectable platelet rich fibrin (i-PRF) along with microneedling on gingival thickness in patients with thin gingival phenotype undergoing non extraction fixed orthodontic treatment Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Thin-gingiva
- What is being tested?
- Injectable PRF and Microneedling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2021to 25 Aug 2022
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • GT of the mandibular anterior teeth <1mm (jepson et al. 2018) requiring labial orthodontic tooth movement without extraction.
- Patients with > 18 years who will be systemically healthy
- full-mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%
- gingival index (GI) of <1 (loe and silness) and dehiscence in mandibular anterior teeth detected in CBCT;
Who cannot join
- Patients with thick gingival biotype (>1mm gingival thickness as per Jepson et al.,2018) ;
- Patient undergoing dental extraction for labial orthodontic tooth movement.
- previous periodontal surgery;
- systemic disease;
- smokers
- use of blood thinners;
- use of any drugs that might lead to gingival enlargement;
- mucogingival stress, bruxism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Title: Effect Of Injectable Platelet Rich Fibrin With Microneedling On Thin Gingival Phenotype In Fixed Non Extraction Orthodontic Cases - A Randomized Controlled Clinical Trial
To evaluate the effect injectable platelet rich fibrin (i-PRF) along with microneedling on gingival thickness in patients with thin gingival phenotype undergoing non extraction fixed orthodontic treatment
Read the detailed description
A non surgical, non invasive method of increasing gingival thickness has been reported using injectable platelet rich fibrin (i-PRF) alone and with microneedling (MN) in individuals with thin periodontal phenotype .
I-PRF is prepared as per low speed centrifugation concept that can provide a significant advantage for the regeneration process as it is rich in platelets, leukocytes, growth factors (As iprf is rich in WBC'c enabling slow and sustained release of growth factors as it clots and forms a gel approximately after 10-15 min and preserve its contents in the tissue for sustained release and inducing the expression of transforming growth factor-β11 and collagen-1 mRNA11, cellular fibroblasts11 and osteoblasts migration10 and collagen-1 synthesis10 .
Microneedling (MN) is also called as "percutaneous collagen induction therapy"9. Microinjuries created by MN result in minimal superficial bleedings and create a wound healing cascade which includes neocollagenesis and neoangiogenesis from which various growth factors, such as platelet derived growth factors, transforming growth factors, connective tissue growth factor and fibroblast growth factors are released9.
Primary therapeutic goal of this study is to do preorthodontic gingival augmentation using a latest technique injectable platelet rich fibrin (iprf) along with microneedling (MN) to increase the buccolingual thickness of marginal tissues over teeth that creates more robust marginal tissues that are less susceptible to trauma or plaque related inflammation and subsequent recession.
AIM : The primary aim of the study is to evaluate the effect injectable platelet rich fibrin (i-PRF) along with microneedling on gingival thickness in patients with thin gingival phenotype undergoing non extraction fixed orthodontic treatment.
OBJECTIVES
PRIMARY OBJECTIVE :
- To measure and compare gingival tissue thickness in mandibular anteriors in patients requiring labial orthodontic movement (in non extraction cases) with thin gingival phenotype by using injectable platelet rich fibrin and microneedling (TEST GROUP) without using injectable platelet rich fibrin and microneedling(CONTROL GROUP ).
SECONDARY OBJECTIVE :
- To evaluate keratinized tissue width ( KTW ) in mandibular anteriors in patients requiring labial orthodontic movement without extraction by using injectable platelet rich fibrin (TEST GROUP) and without using injectable platelet rich fibrin(CONTROL GROUP ).
- To measure and compare effect of microneedling and i-PRF on periodontal parameter PI,GI,BOP,PD,CAL in mandibular anteriors in patients requiring labial orthodontic movement in non extraction cases.
INTERVENTION
IN TEST GROUP :
Local anaesthesia in the form of xylocaine HCL (2%) will be administered. i-PRF Preparation : A venous blood sample will be taken once for each patient using a 20 ml injector will be separated into two PRF tubes of 10 ml each containing no anticoagulant and centrifuged at room temperature with choukron's protocol. The i-PRFs obtained will be placed in 2.5cc dental injectors. The 27-gauge dental injector needles will be used for injection of i-PRF.
Microneedling Procedure :
Thirty-gauge (0.255 mm) lancet needles will be vertically inserted into the tissue until the hard tissue will reach. MN will be carried out on keratinized gingiva from the mesial line of the central tooth to the distal part of the canine tooth to be treated with the help of a lancet.
After one week post scaling, sites will be treated with i-PRF and microneedling. A total of 4 sessions will be done with an interval of 10 days each.
IN CONTROL GROUP :
Patients undergoing orthodontic treatment for labial retraction of mandibular anteriors with thin gingival phenotype will be kept under observation for 6 months for gingival phenotype with follow up.
STUDY DESIGN AND SETTING The present prospective, analytical, randomized clinical trial, single blinded study was conducted in the Department of PERIODONTOLOGY, Post Graduate Institute Of Dental Sciences, Rohtak.
STUDY PERIOD MARCH 2021 to 2022 JULY FOLLOW UP 6 months STUDY SUBJECTS TEST GROUP = 18 CONTROL GROUP = 18
- Conditions
- Thin-gingiva
- Being tested
- Injectable PRF and Microneedling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable PRF and MicroneedlingProcedure or surgery
i-PRF and Microneedling Procedure in thin gingiva followed by orthodontic treatment
| Study group | Role | What they receive |
|---|---|---|
| TEST GROUP | Experimental | i-PRF and Microneedling Procedure in thin gingiva followed by orthodontic treatment Receives: Procedure: Injectable PRF and Microneedling |
| CONTROL GROUP | No intervention | no periodontal intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival tissue thickness (GTT)
Change in Gingival tissue thickness from baseline to 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Mar 2021
- Primary completion15 Jul 2022 (estimated)
- Study completion25 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thin-gingivaStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MRINALINI VERMA, BDS, Principal investigator, PGIDS, ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449925
- Sponsor's protocol ID
- Mrinalini Verma Perio
- Status last verified
- Jul 2022
- First submitted
- 30 May 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title: Effect Of Injectable Platelet Rich Fibrin With Microneedling On Thin Gingival Phenotype In Fixed Non Extraction Orthodontic Cases - A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05449925
- Acronym / sponsor ID
- Mrinalini Verma Perio
- Conditions
- Thin-gingiva
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 25 Aug 2022 (estimated)
- First posted
- 8 Jul 2022 (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.
To evaluate the effect injectable platelet rich fibrin (i-PRF) along with microneedling on gingival thickness in patients with thin gingival phenotype undergoing non extraction fixed orthodontic treatment
Detailed description
A non surgical, non invasive method of increasing gingival thickness has been reported using injectable platelet rich fibrin (i-PRF) alone and with microneedling (MN) in individuals with thin periodontal phenotype .
I-PRF is prepared as per low speed centrifugation concept that can provide a significant advantage for the regeneration process as it is rich in platelets, leukocytes, growth factors (As iprf is rich in WBC'c enabling slow and sustained release of growth factors as it clots and forms a gel approximately after 10-15 min and preserve its contents in the tissue for sustained release and inducing the expression of transforming growth factor-β11 and collagen-1 mRNA11, cellular fibroblasts11 and osteoblasts migration10 and collagen-1 synthesis10 .
Microneedling (MN) is also called as "percutaneous collagen induction therapy"9. Microinjuries created by MN result in minimal superficial bleedings and create a wound healing cascade which includes neocollagenesis and neoangiogenesis from which various growth factors, such as platelet derived growth factors, transforming growth factors, connective tissue growth factor and fibroblast growth factors are released9.
Primary therapeutic goal of this study is to do preorthodontic gingival augmentation using a latest technique injectable platelet rich fibrin (iprf) along with microneedling (MN) to increase the buccolingual thickness of marginal tissues over teeth that creates more robust marginal tissues that are less susceptible to trauma or plaque related inflammation and subsequent recession.
AIM : The primary aim of the study is to evaluate the effect injectable platelet rich fibrin (i-PRF) along with microneedling on gingival thickness in patients with thin gingival phenotype undergoing non extraction fixed orthodontic treatment.
OBJECTIVES
PRIMARY OBJECTIVE :
- To measure and compare gingival tissue thickness in mandibular anteriors in patients requiring labial orthodontic movement (in non extraction cases) with thin gingival phenotype by using injectable platelet rich fibrin and microneedling (TEST GROUP) without using injectable platelet rich fibrin and microneedling(CONTROL GROUP ).
SECONDARY OBJECTIVE :
- To evaluate keratinized tissue width ( KTW ) in mandibular anteriors in patients requiring labial orthodontic movement without extraction by using injectable platelet rich fibrin (TEST GROUP) and without using injectable platelet rich fibrin(CONTROL GROUP ).
- To measure and compare effect of microneedling and i-PRF on periodontal parameter PI,GI,BOP,PD,CAL in mandibular anteriors in patients requiring labial orthodontic movement in non extraction cases.
INTERVENTION
IN TEST GROUP :
Local anaesthesia in the form of xylocaine HCL (2%) will be administered. i-PRF Preparation : A venous blood sample will be taken once for each patient using a 20 ml injector will be separated into two PRF tubes of 10 ml each containing no anticoagulant and centrifuged at room temperature with choukron's protocol. The i-PRFs obtained will be placed in 2.5cc dental injectors. The 27-gauge dental injector needles will be used for injection of i-PRF.
Microneedling Procedure :
Thirty-gauge (0.255 mm) lancet needles will be vertically inserted into the tissue until the hard tissue will reach. MN will be carried out on keratinized gingiva from the mesial line of the central tooth to the distal part of the canine tooth to be treated with the help of a lancet.
After one week post scaling, sites will be treated with i-PRF and microneedling. A total of 4 sessions will be done with an interval of 10 days each.
IN CONTROL GROUP :
Patients undergoing orthodontic treatment for labial retraction of mandibular anteriors with thin gingival phenotype will be kept under observation for 6 months for gingival phenotype with follow up.
STUDY DESIGN AND SETTING The present prospective, analytical, randomized clinical trial, single blinded study was conducted in the Department of PERIODONTOLOGY, Post Graduate Institute Of Dental Sciences, Rohtak.
STUDY PERIOD MARCH 2021 to 2022 JULY FOLLOW UP 6 months STUDY SUBJECTS TEST GROUP = 18 CONTROL GROUP = 18
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST GROUP | Experimental | Procedure: Injectable PRF and Microneedlingi-PRF and Microneedling Procedure in thin gingiva followed by orthodontic treatment |
| CONTROL GROUP | No intervention | –no periodontal intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • GT of the mandibular anterior teeth <1mm (jepson et al. 2018) requiring labial orthodontic tooth movement without extraction.
Key exclusion criteria (8 listed)
- Patients with thick gingival biotype (>1mm gingival thickness as per Jepson et al.,2018) ;
- Patient undergoing dental extraction for labial orthodontic tooth movement.
- previous periodontal surgery;
- systemic disease;
- 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 |
|---|---|---|
| Injectable PRF and Microneedlingi-PRF and Microneedling Procedure in thin gingiva followed by orthodontic treatment | Procedure or surgery | TEST GROUP |
Primary outcome
Change in Gingival tissue thickness (GTT)
Time frame: 6 months
Change in Gingival tissue thickness from baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Thin-gingiva
Recruiting
Evaluation of Different Grafting Technique of Thin Gingival Phenotype With Delayed Dental Implants
Implant Dentistry, Connective Tissue Graft
Not yet recruiting
Injectable Platelet-Rich Fibrin and Microneedling With or Without Vitamin C for Gingival Phenotype Augmentation.
Thin Gingival Phenotype
Not yet recruiting
Dimensional Changes: Randomized Clinical Trial
Gingival Recession
Recruiting
Gain of Keratinized Mucosa Around Teeth and Dental Implants Using a Combination of Strip Gingival Graft and Acellular Dermal Matrix
Gingival Recession, Lack of Keratinized Attached Peri-implant Mucosa
Not yet recruiting
Super Putty C-PRF/ Hyaluronic Acid Combination vs C-PRF in Gingival Phenotype Modification in Subjects With Thin Gingival Phenotype
Thin Gingival Phenotype
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.
MRINALINI VERMA, BDS principal investigator
PGIDS, ROHTAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable PRF and Microneedling in people with Thin-gingiva, run by Postgraduate Institute of Dental Sciences Rohtak 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 4 inclusion and 8 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 8 Jul 2022. 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.
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?
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?
Change in Gingival tissue thickness (GTT) (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 8 Jul 2022.