Gingival PigmentationPhase 4NCT05283668
Effect of Injectable Platelet Rich Fibrin on Healing and Patient Satisfaction Following Laser Gingival Depigmentation
A Phase 4 study testing i-PRF and Diode Laser in people with Gingival Pigmentation, run by Ain Shams University at 1 site in Egypt.
Trial summary
The objectives of the present study are to: 1. Evaluate the effect of I-PRF injection following laser gingival depigmentation technique on the healing period as a primary objective. 2. Assess patient satisfaction following the procedure in terms of pain and esthetic outcome as a secondary objective. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Gingival Pigmentation
- What is being tested?
- i-PRF and Diode Laser
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2020to 30 Jan 2022
- 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female with age range from 16 to 45 years old.
- Systemically free from any disease as evidenced by the health questionnaire guided by modified Cornell medical index (Pendleton et al., 2004).
- Gingival hyperpigmentation on maxillary and mandibular labial keratinized gingiva score 3 (Dummett et al., 1964).
- Patient with thick gingival phenotype (>1.5mm) (Claffey and Shanley, 1986).
Who cannot join
- Pregnant and lactating women.
- Smokers.
- Gingival pigmentation associated with occupational Hazards.
- Patients with missing anterior teeth.
- Patients with any metallic restoration related to anterior teeth or undergoing orthodontic treatment.
- Vulnerable groups (prisoners, handicapped and orphans).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Adjunctive Effect of Injectable Platelet Rich Fibrin on Healing and Patient Satisfaction Following Laser Gingival Depigmentation (A Randomized Clinical Trial With Histological Analysis)
The objectives of the present study are to:
- Evaluate the effect of I-PRF injection following laser gingival depigmentation technique on the healing period as a primary objective.
- Assess patient satisfaction following the procedure in terms of pain and esthetic outcome as a secondary objective.
Read the detailed description
Dental esthetic needs are increasing in recent years with a greater demand on pleasant appearance; including a healthy set of dentitions but also esthetically improved gingival appearance, especially when it is located in the anterior labial region. Physiologic gingival hyperpigmentation affects numerous people of different ethnic backgrounds.
Gingival depigmentation is defined as a periodontal plastic surgical procedure that are aimed at removing the pigmented gingiva and methods aimed at masking the pigmented gingiva. Techniques of gingival depigmentation can be classified as; chemical methods mainly by ascorbic acids, surgical methods, electrosurgery, cryosurgery, radiosurgery, and lasers.
The study was conducted on eight patients seeking treatment for their gingival hyperpigmentation for esthetic reasons. A total number of 16 sites of facial gingival hyperpigmentation were treated, two in each patient in a split mouth technique.
- Group I (LASER with I-PRF): Included eight sites that were treated with laser technique for gingival depigmentation, followed by intramucosal field injection of I-PRF (as study group).
- Group II (LASER): Included eight sites that were treated with laser technique for gingival depigmentation (as a control group).
The clinical outcomes were assessed for each patient: at baseline (pre-operative), post-operative, one week, one month. Clinical assessment was done by measuring DOPI, clinical wound healing, VAS and patient satisfaction questionnaire.
- Conditions
- Gingival Pigmentation
- Being tested
- i-PRF, Diode Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-PRFBiological
- Local anesthesia was achieved using field block technique.
- A soft tissue diode surgical laser unit was used in a contact method using a flexible fiber optic hand piece with initiated tip.
- Laser irradiation parameters were adjusted as follows: Wavelength [940 ± 10 nm], irradiation mode [contact continuous wave], Power [2 W] and 300 μm fiber tip diameter (Jokar et al., 2019).
- The treatment was depigmentation by laser thin injection by I-PRF Post-operative instructions Instruct the patients to avoid tooth brushing on the day of surgical treatment to prevent mechanical trauma and allow re-epithelialization.
Diode LaserProcedure or surgery
Local anesthesia was achieved using field block technique.
- A soft tissue diode surgical laser unit was used in a contact method using a flexible fiber optic hand piece with initiated tip.
- Laser irradiation parameters were adjusted as follows: Wavelength [940 ± 10 nm], irradiation mode [contact continuous wave], Power [2 W] and 300 μm fiber tip diameter (Jokar et al., 2019).
Post-operative instructions Instruct the patients to avoid tooth brushing on the day of surgical treatment to prevent mechanical trauma and allow re-epithelialization.
| Study group | Role | What they receive |
|---|---|---|
| (LASER WITH I-PRF) | Experimental | Eight sites that were treated with laser method for gingival depigmentation, followed by intra-mucosal field injection of I-PRF Receives: Biological: i-PRF; Procedure: Diode Laser |
| (LASER WITHOUT I-PRF) | Active comparator | Eight sites that were treated with laser technique for gingival depigmentation only Receives: Procedure: Diode Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dummet oral pigmentation index
the degree of gingival pigmentation will be scored as: 0 = pink tissue [no clinical pigmentation]; 1 = mild light brown tissue [mild clinical pigmentation]; 2 = medium brown or mixed brown and pink tissue [moderate clinical pigmentation]; or 3 = deep brown/ blue-black tissue [heavy clinical pigmentation]
Measured: 1 month
Clinical wound healing
scored as follows:
- Complete reepithelialization, 2) Incomplete reepithelialization, 3) ulcer and 4) tissue defect or necrosis
Measured: 1 week
Secondary outcomes (3)
Satisfaction questionnaire
score the degree of satisfaction about cosmetic outcomes of treatment
Measured: 1month
Visual analogue scale (VAS) score for pain assessment
Pain assessment will be performed using a 10-cm (100 mm) horizontal continuous scale marked "no pain" on the left and "maximum pain" on the right side of the scale. The scores were as follows: no pain (0), slight pain (0.1-3.0 mm), moderate pain (3.1-6.0 mm), and severe pain (6.1-10 mm)
Measured: 1month
Histological assessment
The mean of epithelial thickness for each case was calculated
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start20 Feb 2020
- Primary completion20 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival PigmentationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Mohamed Ezzatt, Ain Shams University
- Investigators
- Ola Ezzatt, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283668
- Sponsor's protocol ID
- FD-ASU -2021
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available on request at principle investigator
Publications
Ibrahim SSA, Mandil IA, Ezzatt OM. Injectable platelet rich fibrin effect on laser depigmented gingiva: a clinical randomized controlled split mouth trial with histological assessment. J Appl Oral Sci. 2024 Mar 25;32:e20230307. doi: 10.1590/1678-7757-2022-0307. eCollection 2024.
PubMed 38536994
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjunctive Effect of Injectable Platelet Rich Fibrin on Healing and Patient Satisfaction Following Laser Gingival Depigmentation (A Randomized Clinical Trial With Histological Analysis)
- ClinicalTrials.gov ID
- NCT05283668
- Acronym / sponsor ID
- FD-ASU -2021
- Conditions
- Gingival Pigmentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 17 Mar 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.
The objectives of the present study are to:
- Evaluate the effect of I-PRF injection following laser gingival depigmentation technique on the healing period as a primary objective.
- Assess patient satisfaction following the procedure in terms of pain and esthetic outcome as a secondary objective.
Detailed description
Dental esthetic needs are increasing in recent years with a greater demand on pleasant appearance; including a healthy set of dentitions but also esthetically improved gingival appearance, especially when it is located in the anterior labial region. Physiologic gingival hyperpigmentation affects numerous people of different ethnic backgrounds.
Gingival depigmentation is defined as a periodontal plastic surgical procedure that are aimed at removing the pigmented gingiva and methods aimed at masking the pigmented gingiva. Techniques of gingival depigmentation can be classified as; chemical methods mainly by ascorbic acids, surgical methods, electrosurgery, cryosurgery, radiosurgery, and lasers.
The study was conducted on eight patients seeking treatment for their gingival hyperpigmentation for esthetic reasons. A total number of 16 sites of facial gingival hyperpigmentation were treated, two in each patient in a split mouth technique.
- Group I (LASER with I-PRF): Included eight sites that were treated with laser technique for gingival depigmentation, followed by intramucosal field injection of I-PRF (as study group).
- Group II (LASER): Included eight sites that were treated with laser technique for gingival depigmentation (as a control group).
The clinical outcomes were assessed for each patient: at baseline (pre-operative), post-operative, one week, one month. Clinical assessment was done by measuring DOPI, clinical wound healing, VAS and patient satisfaction questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (LASER WITH I-PRF) | Experimental | Biological: i-PRF, Procedure: Diode LaserEight sites that were treated with laser method for gingival depigmentation, followed by intra-mucosal field injection of I-PRF |
| (LASER WITHOUT I-PRF) | Active comparator | Procedure: Diode LaserEight sites that were treated with laser technique for gingival depigmentation only |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male and female with age range from 16 to 45 years old.
- Systemically free from any disease as evidenced by the health questionnaire guided by modified Cornell medical index (Pendleton et al., 2004).
- Gingival hyperpigmentation on maxillary and mandibular labial keratinized gingiva score 3 (Dummett et al., 1964).
- Patient with thick gingival phenotype (>1.5mm) (Claffey and Shanley, 1986).
Key exclusion criteria (6 listed)
- Pregnant and lactating women.
- Smokers.
- Gingival pigmentation associated with occupational Hazards.
- Patients with missing anterior teeth.
- Patients with any metallic restoration related to anterior teeth or undergoing orthodontic treatment.
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 |
|---|---|---|
| i-PRF* Local anesthesia was achieved using field block technique. * A soft tissue diode surgical laser unit was used in a contact method using a flexible fiber optic hand piece with initiated tip. * Laser irradiation parameters were adjusted as follows: Wavelength [940 ± 10 nm], irradiation mode [contact continuous wave], Power [2 W] and 300 μm fiber tip diameter (Jokar et al., 2019). * The treatment was depigmentation by laser thin injection by I-PRF Post-operative instructions Instruct the patients to avoid tooth brushing on the day of surgical treatment to prevent mechanical trauma and allow re-epithelialization. | Biological | (LASER WITH I-PRF) |
| Diode LaserLocal anesthesia was achieved using field block technique. * A soft tissue diode surgical laser unit was used in a contact method using a flexible fiber optic hand piece with initiated tip. * Laser irradiation parameters were adjusted as follows: Wavelength [940 ± 10 nm], irradiation mode [contact continuous wave], Power [2 W] and 300 μm fiber tip diameter (Jokar et al., 2019). Post-operative instructions Instruct the patients to avoid tooth brushing on the day of surgical treatment to prevent mechanical trauma and allow re-epithelialization. | Procedure or surgery | (LASER WITH I-PRF), (LASER WITHOUT I-PRF) |
Primary outcome
Dummet oral pigmentation index
Time frame: 1 month
the degree of gingival pigmentation will be scored as: 0 = pink tissue [no clinical pigmentation]; 1 = mild light brown tissue [mild clinical pigmentation]; 2 = medium brown or mixed brown and pink tissue [moderate clinical pigmentation]; or 3 = deep brown/ blue-black tissue [heavy clinical pigmentation]
Clinical wound healing
Time frame: 1 week
scored as follows: 1) Complete reepithelialization, 2) Incomplete reepithelialization, 3) ulcer and 4) tissue defect or necrosis
3 secondary outcomes
Satisfaction questionnaire
Time frame: 1month
Visual analogue scale (VAS) score for pain assessment
Time frame: 1month
Histological assessment
Time frame: 1 week
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 17 Mar 2022.
- Derived from this study: PubMed 38536994Ibrahim SSA, Mandil IA, Ezzatt OM. Injectable platelet rich fibrin effect on laser depigmented gingiva: a clinical randomized controlled split mouth trial with histological assessment. J Appl Oral Sci. 2024 Mar 25;32:e20230307. doi: 10.1590/1678-7757-2022-0307. eCollection 2024.
- Individual participant dataSharing planned: No. Available on request at principle investigator
Related trials for Gingival Pigmentation
Not yet recruiting
Gingival Depigmentation Using a 940 nm Diode Laser Versus Ceramic Bur
Physiologic Gingival Melanin Pigmentation
Enrolling by invitationPhase 3
Evaluation of the Efficacy of Topical Application of Liquid Nitrogen and Ascorbic Acid in Treatment of Gingival Pigmentation
Gingival Pigmentation, Gingiival Hyperpigmentation
Not yet recruiting
Influence of Adjunctive Acids Use on Esthetic Outcomes of Gingival Melanin Depigmentation: A Periodontal-Operative Pilot Randomized Clinical Trial
Gingival Pigmentation
Recruiting
Effect of Co-enzyme Q10 and Vitamin C Alone or in Combination After a Surgical Gingival Depigmentation
Depigmentation Treatment, Depigmentation
RecruitingPhase 2
Gingival Hyperpigmentation Treatment
Gingival Pigmentation, Depigmentation
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.
Ola Ezzatt principal investigator
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 i-PRF and Diode Laser in people with Gingival Pigmentation, run by Ain Shams 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 4 inclusion and 6 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 17 Mar 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 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?
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?
Dummet oral pigmentation index (time frame: 1 month). The study lists 2 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 NCT05283668, which also lists 1 linked publication.
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 17 Mar 2022.