Thin Gingival BiotypePhase 4NCT05841303
Comparative Evaluation of Vitamin C and Injectable-platelet Rich Fibrin in the Management of Thin Gingival Phenotype
A Phase 4 study testing Vit C and injectable PRF in people with Thin Gingival Biotype, run by Cairo University at 1 site in Egypt.
Trial summary
The goal is to compare between the effect of vitamin C and Injectable-platelet rich fibrin in the management of thin gingival phenotype. The main question: ln patients with thin phenotype, will injecting Vitamin C with micro needles increase the gingival thickness compared to injecting injectable-platelet rich fibrin… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Thin Gingival Biotype
- What is being tested?
- Vit C and injectable PRF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Nov 2024
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy individuals of age ≥ 18 to 40 years with absence of active periodontal disease.
- Having thin gingival phenotype <1.5mm.
- No systemic disease according to Modified Cornell Medical Index health questionnaire.
- Non-smoker.
- Full mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
- No malocclusion, crowding, fillings, missing or supernumerary mandibular anterior teeth.
- No blood-borne conditions.
Who cannot join
- Active orthodontic treatment.
- Previous periodontal surgery.
- Systemic disease.
- Use of blood thinners.
- Use of any drugs that might lead to gingival enlargement.
- Mucogingival stress, bruxism.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Manar Elzanaty, Ass. Lecturer contact
About this study
Official title: Comparative Evaluation of Vitamin C and Injectable-platelet Rich Fibrin in the Management of Thin Gingival Phenotype: A Split-mouth Randomized Clinical Trial.
- The goal is to compare between the effect of vitamin C and Injectable-platelet rich fibrin in the management of thin gingival phenotype.
- The main question: ln patients with thin phenotype, will injecting Vitamin C with micro needles increase the gingival thickness compared to injecting injectable-platelet rich fibrin with micro needles?
- After enrolment, periodontal examination and measurement of periodontal probing depth (PD), patients with a high periodontal probe visibility in the anterior teeth will be identified. These patients will undergo gingival thickness (GT) measurement using trans gingival probing technique in the anterior teeth, and those with a measured GT of ≤ 1.5mm will be diagnosed with thin phenotype.
- Keratinized tissue width will be measured.
- Micro needle the gingival mucosa by using derma pen device which will be used in intermittent motion on the sextant gingival area for 30-40 seconds/tooth. When bleeding pinpoints observed on all areas of attached gingiva.
- Intervention group: Vitamin C injection will be injected with microneedle at two points for each site in the attached gingiva of right or left (split mouth) at 3 mm apical to the free gingival margin in the facial side of the tooth until the blanching of the gingiva will be seen and apical to the mucogingival junction.
- Control group: 1.Preparation and administration of injectable platelets rich fibrin (i-PRF). I-PRF will be injected on the site with thin gingival phenotype on the other side of the jaw in the same patient (split mouth technique) with micro needling same way as vitamin C group. 3.Vitamin C and I-PRF will again be injected at the same site after 1 week and after 2 weeks from the baseline final injection which will be given.
Outcomes: The results for the mean gingival thickness (GT), keratinized tissue width (kTW), pocket depth (PD), and gingival index (GI) at baseline, 1 month, 3 months and after 6 months
Read the detailed description
Research objective: The aim of conducting this research is development of newer, less invasive therapeutic approaches that help in prevention of gingival recession. As thin gingival biotype is more prone to gingival recession and to achieve satisfactory therapeutic results with minimum trauma to tissues of any interventional process.
Research Procedure in brief:
This study will be carried out on patients enrolled from the Outpatient Clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University.
General operative procedures
- The patients who fulfil the inclusion criteria will be enrolled. The nature of the study will be explained to each patient as well as the importance of compliance with pre- and post-operative instructions and follow-up visits.
- Each patient will be asked to sign an informed consent (appendix 1)
- After enrolment, periodontal examination and measurement of periodontal probing depth (PD), patients with a high periodontal probe visibility in the anterior teeth will be identified. These patients will undergo gingival thickness (GT) measurement using trans gingival probing technique in the anterior teeth, and those with a measured GT of ≤ 1.5mm will be diagnosed with thin phenotype.
- The methods used for evaluation of gingival thickness included Visual assessment with aid of probe and direct measurement by #15 endodontic spreader will be inserted trans gingivally into the anaesthetized selected site (anaesthetized with Lidocaine 10% spray), stopper will be used as the reference point and the exact measurement will be recorded with the help of endo-ruler or caliber.
- Keratinized tissue width will be measured from gingival margin to mucogingival junction with the help of calibrated periodontal probe (UNC 15 probe).
- As a preliminary routine, supragingival scaling will be performed and oral hygiene instructions will be provided by the dental hygienist. We subsequently will schedule the procedure and perform it aseptically.
- The area to be injected will be anesthetized. To microneedle the gingival mucosa, we will use a derma pen device model M8 with 24 microneedles arranged in rows, which will be adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The derma pen will be used in intermittent motion on the sextant gingival area for 30-40 seconds/tooth. When bleeding pinpoints observed on all areas of attached gingiva, the gingival mucosa will be irrigated with a saline solution and sterile gauze will be applied to dry the area.
- Intervention group: Vitamin C injection will be injected with microneedle at two points for each site in the attached gingiva of one site of the jaw either the left or the right side and the other side will be injected with injectable platelets rich fibrin (i-PRF) as a control group at 3 mm apical to the free gingival margin in the facial side of the tooth until the blanching of the gingiva will be seen and apical to the mucogingival junction. The treated area will be left without dressing. The patient will be instructed to refrain from drinking acidic or hot beverages for 24 hours and to not brush the teeth of the injected area for one day to avoid any mechanical trauma to the gingiva. Following the procedure, neither mouthwashes nor medications will be prescribed.
- Control group:
- Preparation and administration of injectable platelets rich fibrin (i-PRF): After collection of 5 ml of peripheral blood from each patient, blood will be transferred to a glass coated plastic vacutainer tube without anticoagulant. Then this tube will immediately centrifuged at 700 rpm for 3 mins [Centrifuge Machine 5000rpm]. After centrifugation, two fluid layers will formed, upper being yellow fluid layer (i-PRF) while lower layer containing red blood cells. Yellow fluid layer containing i-PRF will be immediately aspirated using micro needle.
- I-PRF will be injected on the site with thin gingival phenotype on the other side of the jaw in the same patient (split mouth technique) with micro needling with derma pen at two points for each site in the attached gingiva at 3 mm apical to the free gingival margin in the facial side of the tooth until the blanching of the gingiva was seen and apical to the mucogingival junction.
- Vitamin C and I-PRF will again be injected at the same site after 1 week and after 2 weeks from the baseline final injection which will be given.
Outcomes: The results for the mean gingival thickness (GT), keratinized tissue width (kTW), pocket depth (PD), and gingival index (GI) at baseline, 1 month, 3 months and after 6 months.
- Conditions
- Thin Gingival Biotype
- Being tested
- Vit C, injectable PRF
- Keywords
- Thin gingival biotype, Vitamin C, i-PRF, Microneedle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vit CDrug
Also called Ascorbic acid
Vit c is proven to be an anti-inflammatory and antioxidant agent. also play a great role in collagen biosynthesis (collagen type I), as it helps in fibroblasts proliferation. It reduces the potentiality of scaring via inhibiting cross-linking of collagen fibers and fibrosis. It acts as a cofactor in hydroxyproline synthesis to produce collagen type IV and improves endothelial cell vitality and function..
injectable PRFOther
Also called i-PRF
5 ml of peripheral blood from each patient , blood will be transferred to a glass coated plastic vacutainer tube without anticoagulant. Then this tube will immediately centrifuged at 700 rpm for 3 mins [Centrifuge Machine 5000rpm.After centrifugation, two fluid layers will formed, upper being yellow fluid layer (i-PRF) while lower layer containing red blood cells. Yellow fluid layer containing i-PRF will be immediately aspirated using micro needle to be injected for management of gingival phenotype
| Study group | Role | What they receive |
|---|---|---|
| Vit. C injection | Experimental | Derma pen device model M8 with 24 -micro needle will be adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min with intermittent motion used on the sextant gingival area for 30-40 seconds/tooth.
vitamin C will be injected with microneedle at two points for each site in the attached gingiva of one site of the jaw either the left or the right side at 3 mm apical to the free gingival margin in the facial side of the tooth until the blanching of the gingiva will be seen and apical to the mucogingival junction.
- Vitamin C will again be injected at the same site after 1 week and after 2 weeks from the baseline final injection which will be given. Receives: Drug: Vit C |
| Injectable-platelet Rich Fibrin (i-PRF) | Active comparator | The derma pen will be used same as vitamin C group. I-PRF will be immediately aspirated using micro needle. I-PRF will be injected on the site with thin gingival phenotype (split mouth technique) with micro needling with derma pen at two points for each site in the attached gingiva at 3 mm apical to the free gingival margin in the facial side of the tooth until the blanching of the gingiva was seen and apical to the mucogingival junction.
4. I-PRF will again be injected at the same site after 1 week and after 2 weeks from the baseline final injection which will be given. Receives: Other: injectable PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival thickness (GT) change from baseline to 6months.
GT will be measured using a no. 15 endodontic spreader (the file will be inserted perpendicularly through the gingiva, 2 mm apical to the gingival margin through the soft tissue until a hard surface reached). The flowable light-curing composite will be used to mark the penetration thickness on the spreader. Then, caliper or endo. Ruler will be used to measure the penetration thickness between the spreader's tip and the light-cured composite.
Measured: GT will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Secondary outcomes (4)
Keratinized tissue width (KTW) change from baseline to 6months.
The KTW will be calculated from the gingival margin to the mucogingival junctions with the help of a periodontal probe (UNC-15).
Measured: The KTW. will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Gingival index (GI)change from baseline to 6months.
The GI is used to assess the gingival condition based on the following criteria 0=normal gingiva.
- mild inflammation (slight change in color and slight edema but no BOP).
- moderate inflammation (redness, edema, and glazing, bleeding on probing).
- severe inflammation (marked redness and edema, ulceration with tendency to spontaneous bleeding).
The scores of the four areas of the tooth (buccal, mesial, distal, lingual) can be summed and divided by four to give the GI for the tooth.
Measured: GI. will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Plaque index (PI) change from baseline to 6months.
PI will be measured using UNC periodontal probe at six sites per tooth.
Measured: PI will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Probing depth. (PD) change from baseline to 6months.
PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using UNC periodontal probe at six sites per tooth
Measured: PD. will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jul 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thin Gingival BiotypeStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Split-mouth Randomized Clinical Trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mahmoud Mohamed Mohamed Abdelhay, Cairo University
- Investigators
- Riham M. Omar, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841303
- Sponsor's protocol ID
- 13123PER 3_3_1
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 3 May 2023
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Vitamin C and Injectable-platelet Rich Fibrin in the Management of Thin Gingival Phenotype: A Split-mouth Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05841303
- Acronym / sponsor ID
- 13123PER 3_3_1
- Conditions
- Thin Gingival Biotype
- Keywords
- Thin gingival biotype, Vitamin C, i-PRF, Microneedle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 3 May 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.
- The goal is to compare between the effect of vitamin C and Injectable-platelet rich fibrin in the management of thin gingival phenotype.
- The main question: ln patients with thin phenotype, will injecting Vitamin C with micro needles increase the gingival thickness compared to injecting injectable-platelet rich fibrin with micro needles?
- After enrolment, periodontal examination and measurement of periodontal probing depth (PD), patients with a high periodontal probe visibility in the anterior teeth will be identified. These patients will undergo gingival thickness (GT) measurement using trans gingival probing technique in the anterior teeth, and those with a measured GT of ≤ 1.5mm will be diagnosed with thin phenotype.
- Keratinized tissue width will be measured.
- Micro needle the gingival mucosa by using derma pen device which will be used in intermittent motion on the sextant gingival area for 30-40 seconds/tooth. When bleeding pinpoints observed on all areas of attached gingiva.
- Intervention group: Vitamin C injection will be injected with microneedle at two points for each site in the attached gingiva of right or left (split mouth) at 3 mm apical to the free gingival margin in the facial side of the tooth until the blanching of the gingiva will be seen and apical to the mucogingival junction.
- Control group: 1.Preparation and administration of injectable platelets rich fibrin (i-PRF). I-PRF will be injected on the site with thin gingival phenotype on the other side of the jaw in the same patient (split mouth technique) with micro needling same way as vitamin C group. 3.Vitamin C and I-PRF will again be injected at the same site after 1 week and after 2 weeks from the baseline final injection which will be given.
Outcomes: The results for the mean gingival thickness (GT), keratinized tissue width (kTW), pocket depth (PD), and gingival index (GI) at baseline, 1 month, 3 months and after 6 months
Detailed description
Research objective: The aim of conducting this research is development of newer, less invasive therapeutic approaches that help in prevention of gingival recession. As thin gingival biotype is more prone to gingival recession and to achieve satisfactory therapeutic results with minimum trauma to tissues of any interventional process.
Research Procedure in brief:
This study will be carried out on patients enrolled from the Outpatient Clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Cairo University.
General operative procedures
- The patients who fulfil the inclusion criteria will be enrolled. The nature of the study will be explained to each patient as well as the importance of compliance with pre- and post-operative instructions and follow-up visits.
- Each patient will be asked to sign an informed consent (appendix 1)
- After enrolment, periodontal examination and measurement of periodontal probing depth (PD), patients with a high periodontal probe visibility in the anterior teeth will be identified. These patients will undergo gingival thickness (GT) measurement using trans gingival probing technique in the anterior teeth, and those with a measured GT of ≤ 1.5mm will be diagnosed with thin phenotype.
- The methods used for evaluation of gingival thickness included Visual assessment with aid of probe and direct measurement by #15 endodontic spreader will be inserted trans gingivally into the anaesthetized selected site (anaesthetized with Lidocaine 10% spray), stopper will be used as the reference point and the exact measurement will be recorded with the help of endo-ruler or caliber.
- Keratinized tissue width will be measured from gingival margin to mucogingival junction with the help of calibrated periodontal probe (UNC 15 probe).
- As a preliminary routine, supragingival scaling will be performed and oral hygiene instructions will be provided by the dental hygienist. We subsequently will schedule the procedure and perform it aseptically.
- The area to be injected will be anesthetized. To microneedle the gingival mucosa, we will use a derma pen device model M8 with 24 microneedles arranged in rows, which will be adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min. The derma pen will be used in intermittent motion on the sextant gingival area for 30-40 seconds/tooth. When bleeding pinpoints observed on all areas of attached gingiva, the gingival mucosa will be irrigated with a saline solution and sterile gauze will be applied to dry the area.
- Intervention group: Vitamin C injection will be injected with microneedle at two points for each site in the attached gingiva of one site of the jaw either the left or the right side and the other side will be injected with injectable platelets rich fibrin (i-PRF) as a control group at 3 mm apical to the free gingival margin in the facial side of the tooth until the blanching of the gingiva will be seen and apical to the mucogingival junction. The treated area will be left without dressing. The patient will be instructed to refrain from drinking acidic or hot beverages for 24 hours and to not brush the teeth of the injected area for one day to avoid any mechanical trauma to the gingiva. Following the procedure, neither mouthwashes nor medications will be prescribed.
- Control group:
- Preparation and administration of injectable platelets rich fibrin (i-PRF): After collection of 5 ml of peripheral blood from each patient, blood will be transferred to a glass coated plastic vacutainer tube without anticoagulant. Then this tube will immediately centrifuged at 700 rpm for 3 mins [Centrifuge Machine 5000rpm]. After centrifugation, two fluid layers will formed, upper being yellow fluid layer (i-PRF) while lower layer containing red blood cells. Yellow fluid layer containing i-PRF will be immediately aspirated using micro needle.
- I-PRF will be injected on the site with thin gingival phenotype on the other side of the jaw in the same patient (split mouth technique) with micro needling with derma pen at two points for each site in the attached gingiva at 3 mm apical to the free gingival margin in the facial side of the tooth until the blanching of the gingiva was seen and apical to the mucogingival junction.
- Vitamin C and I-PRF will again be injected at the same site after 1 week and after 2 weeks from the baseline final injection which will be given.
Outcomes: The results for the mean gingival thickness (GT), keratinized tissue width (kTW), pocket depth (PD), and gingival index (GI) at baseline, 1 month, 3 months and after 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A Split-mouth Randomized Clinical Trial.
| Arm | Type | Receives |
|---|---|---|
| Vit. C injection | Experimental | Drug: Vit CDerma pen device model M8 with 24 -micro needle will be adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min with intermittent motion used on the sextant gingival area for 30-40 seconds/tooth. vitamin C will be injected with microneedle at two points for each site in the attached gingiva of one site of the jaw either the left or the right side at 3 mm apical to the free gingival margin in the facial side of the tooth until the blanching of the gingiva will be seen and apical to the mucogingival junction. - Vitamin C will again be injected at the same site after 1 week and after 2 weeks from the baseline final injection which will be given. |
| Injectable-platelet Rich Fibrin (i-PRF) | Active comparator | Other: injectable PRFThe derma pen will be used same as vitamin C group. I-PRF will be immediately aspirated using micro needle. I-PRF will be injected on the site with thin gingival phenotype (split mouth technique) with micro needling with derma pen at two points for each site in the attached gingiva at 3 mm apical to the free gingival margin in the facial side of the tooth until the blanching of the gingiva was seen and apical to the mucogingival junction. 4. I-PRF will again be injected at the same site after 1 week and after 2 weeks from the baseline final injection which will be given. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Systemically healthy individuals of age ≥ 18 to 40 years with absence of active periodontal disease.
- Having thin gingival phenotype <1.5mm.
- No systemic disease according to Modified Cornell Medical Index health questionnaire.
- Non-smoker.
- Full mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
Key exclusion criteria (7 listed)
- Active orthodontic treatment.
- Previous periodontal surgery.
- Systemic disease.
- Use of blood thinners.
- Use of any drugs that might lead to gingival enlargement.
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 |
|---|---|---|
| Vit CAlso: Ascorbic acidVit c is proven to be an anti-inflammatory and antioxidant agent. also play a great role in collagen biosynthesis (collagen type I), as it helps in fibroblasts proliferation. It reduces the potentiality of scaring via inhibiting cross-linking of collagen fibers and fibrosis. It acts as a cofactor in hydroxyproline synthesis to produce collagen type IV and improves endothelial cell vitality and function.. | Drug | Vit. C injection |
| injectable PRFAlso: i-PRF5 ml of peripheral blood from each patient , blood will be transferred to a glass coated plastic vacutainer tube without anticoagulant. Then this tube will immediately centrifuged at 700 rpm for 3 mins [Centrifuge Machine 5000rpm.After centrifugation, two fluid layers will formed, upper being yellow fluid layer (i-PRF) while lower layer containing red blood cells. Yellow fluid layer containing i-PRF will be immediately aspirated using micro needle to be injected for management of gingival phenotype | Other | Injectable-platelet Rich Fibrin (i-PRF) |
Primary outcome
Gingival thickness (GT) change from baseline to 6months.
Time frame: GT will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
GT will be measured using a no. 15 endodontic spreader (the file will be inserted perpendicularly through the gingiva, 2 mm apical to the gingival margin through the soft tissue until a hard surface reached). The flowable light-curing composite will be used to mark the penetration thickness on the spreader. Then, caliper or endo. Ruler will be used to measure the penetration thickness between the spreader's tip and the light-cured composite.
4 secondary outcomes
Keratinized tissue width (KTW) change from baseline to 6months.
Time frame: The KTW. will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Gingival index (GI)change from baseline to 6months.
Time frame: GI. will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Plaque index (PI) change from baseline to 6months.
Time frame: PI will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Probing depth. (PD) change from baseline to 6months.
Time frame: PD. will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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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.
Manar Elzanaty, Ass. Lecturer contact
Riham M. Omar, Professor study director
Cairo University
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 Vit C and injectable PRF in people with Thin Gingival Biotype, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 7 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 3 May 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha M. Abdelhay, Bachelor (+02 01092989975, noha_mahmoud@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival thickness (GT) change from baseline to 6months. (time frame: GT will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.). 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 3 May 2023.