Gingival PigmentationEarly Phase 1NCT04495205
Effect of Non-eugenol Periodontal Pack With and Without PRF on Post-operative Pain and Wound Healing After Gingival Depigmentation
A Early Phase 1 study testing PRF under non-eugenol containing periodontal pack and Non-eugenol containing periodontal pack in people with Gingival Pigmentation, run by Cairo University at 1 site in Egypt.
Trial summary
In an era where less than ideal esthetics is not accepted, the request for esthetic procedures is widely sought after. Melanin, a brown pigment, is the most common natural pigment contributing to endogenous pigmentation of gingiva. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Pigmentation
- What is being tested?
- PRF under non-eugenol containing periodontal pack and Non-eugenol containing periodontal pack
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to Mar 2021
- Phase
- Early 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages18-40 years old
- Systemically healthy
- Mild to moderate gingival pigmentations
- Gingival and plaque index <1
- Good oral hygiene
- Thick gingival biotypes
- Keratinized gingiva >2mm
Who cannot join
- Smokers
- Taking any medications that could affect healing
- Pervious depigmentation procedures
- Pregnant or lactating females
- Pervious periodontal surgery within the last 6 months before the start of the trial
- Endodontically treated teeth
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Faculty of Dentistry
Cairo
Mona S Darhous, Professor, 00201223155955, mona.darhous@yahoo.com
About this study
Official title: Clinical Comparison of the Effect of Non-eugenol Containing Periodontal Pack With and Without Platelet Rich Fibrin on Post-operative Pain and Wound Healing After Surgical Gingival Depigmentation: A Randomized Clinical Trial
In an era where less than ideal esthetics is not accepted, the request for esthetic procedures is widely sought after. Melanin, a brown pigment, is the most common natural pigment contributing to endogenous pigmentation of gingiva. It is a non-hemoglobin-derived pigment formed by cells called melaonocytes
Dental cosmetic procedures including gingival depigmentation among the young generation are vastly becoming popular due to the public advertising of what the "ideal smile" should be. This means that brown/ pigmented gingiva is not esthetically accepted by modern standards. Numerous techniques for depigmentation were developed including surgical abrasion, lasers, chemicals and thermal techniques.
Read more
The use of post-operative non-eugenol containing periodontal packs acts as a mechanical barrier for coverage of the denuded area which prevents bleeding and promotes healing by preventing trauma to the area.
Platelet Rich Fibrin (PRF) is a form of concentrated suspension of growth factors that promote healing and tissue regeneration. Its use in the medical and dental fields is expanding during the recent year.
Read the detailed description
Gingival depigmentation procedures especially bur abrasion and scalpel surgical techniques require the use of post-operative periodontal pack. The periodontal pack protects the surgical site from surface trauma, stops the post-operative bleeding and infection as well as stabilizing the blood clot and accelerate healing.
However, a review article discussed the adverse effects of periodontal pack as it may cause plaque induced inflammation, patient discomfort due to difficulty in eating and irritation of the tissues. In the article, there were clinical trials that advocated that wound healing could occur without the need of periodontal pack if the surgical wound was kept clean alone indicating that the pack does not affect the wound healing.
This gave rise to idea to use a material that has been proven to accelerate wound healing and decrease the patient discomfort to be placed under the periodontal pack which would be used only as a protective barrier.
Several studies tested platelet rich concentrates as adjunctive methods under periodontal packs verses periodontal packs alone after surgical abrasion of gingival depigmentation. They found that there was a clinical, histological and statistical difference between the groups favoring the platelet concentrate groups.
Using PRF which is a second generation platelet concentrate first developed by Choukroun et al in 2001 used as a membrane could provide accelerated wound healing properties which would accelerate ginigival re-epithelization . Using a periodontal pack is conventionally used which will provide a mechanical barrier to protect the wound from any stimulus.
- Conditions
- Gingival Pigmentation
- Being tested
- PRF under non-eugenol containing periodontal pack, Non-eugenol containing periodontal pack
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRF under non-eugenol containing periodontal packBiological
Also called Platelet Rich Fibrin
Platelet Rich Fibrin under non-eugenol containing periodontal pack
Non-eugenol containing periodontal packOther
Non-eugenol containing periodontal pack after gingival depigmentation
| Study group | Role | What they receive |
|---|---|---|
| Non-eugenol containing periodontal packs with PRF | Experimental | Non-eugenol containing periodontal packs with PRF after gingival de-pigmentation Receives: Biological: PRF under non-eugenol containing periodontal pack |
| Non-eugenol containing periodontal packs | Placebo comparator | Non-eugenol containing periodontal packs after gingival de-pigmentation Receives: Other: Non-eugenol containing periodontal pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
Measured: 1st day post-operative
Post-operative pain
Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
Measured: 3rd day post-operative
Post-operative pain
Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
Measured: 5th day post-operative
Secondary outcomes (4)
Re-epithelization
Toulodine Blue test: dark blue = positive (worst score), light blue = negative (better score)
Measured: 5th day post-operative
Wound healing
Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)
Measured: 3rd day post-operative
Wound healing
Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)
Measured: 5th day post-operative
Re-pigmentation
Re-pigmentation of de pigmented site (Kumar, Bhat and Bhat, 2012): minimum score 0 (absence of depigmentation, maximum score 3 (Diffuse brown to black pigmentation, marginal, and attached)
Measured: 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Jan 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
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 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Hesham Reda, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495205
- Sponsor's protocol ID
- AHReda
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dahiya R, Blaggana A, Panwar V, Kumar S, Kathuria A, Malik S. Clinical and histological comparison of platelet-rich fibrin versus non-eugenol periodontal dressing in the treatment of gingival hyperpigmentation. J Indian Soc Periodontol. 2019 Jul-Aug;23(4):345-350. doi: 10.4103/jisp.jisp_688_18.
PubMed 31367132
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of the Effect of Non-eugenol Containing Periodontal Pack With and Without Platelet Rich Fibrin on Post-operative Pain and Wound Healing After Surgical Gingival Depigmentation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04495205
- Acronym / sponsor ID
- AHReda
- Conditions
- Gingival Pigmentation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 31 Jul 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.
In an era where less than ideal esthetics is not accepted, the request for esthetic procedures is widely sought after. Melanin, a brown pigment, is the most common natural pigment contributing to endogenous pigmentation of gingiva. It is a non-hemoglobin-derived pigment formed by cells called melaonocytes
Dental cosmetic procedures including gingival depigmentation among the young generation are vastly becoming popular due to the public advertising of what the "ideal smile" should be. This means that brown/ pigmented gingiva is not esthetically accepted by modern standards. Numerous techniques for depigmentation were developed including surgical abrasion, lasers, chemicals and thermal techniques.
The use of post-operative non-eugenol containing periodontal packs acts as a mechanical barrier for coverage of the denuded area which prevents bleeding and promotes healing by preventing trauma to the area.
Platelet Rich Fibrin (PRF) is a form of concentrated suspension of growth factors that promote healing and tissue regeneration. Its use in the medical and dental fields is expanding during the recent year.
Detailed description
Gingival depigmentation procedures especially bur abrasion and scalpel surgical techniques require the use of post-operative periodontal pack. The periodontal pack protects the surgical site from surface trauma, stops the post-operative bleeding and infection as well as stabilizing the blood clot and accelerate healing.
However, a review article discussed the adverse effects of periodontal pack as it may cause plaque induced inflammation, patient discomfort due to difficulty in eating and irritation of the tissues. In the article, there were clinical trials that advocated that wound healing could occur without the need of periodontal pack if the surgical wound was kept clean alone indicating that the pack does not affect the wound healing.
This gave rise to idea to use a material that has been proven to accelerate wound healing and decrease the patient discomfort to be placed under the periodontal pack which would be used only as a protective barrier.
Several studies tested platelet rich concentrates as adjunctive methods under periodontal packs verses periodontal packs alone after surgical abrasion of gingival depigmentation. They found that there was a clinical, histological and statistical difference between the groups favoring the platelet concentrate groups.
Using PRF which is a second generation platelet concentrate first developed by Choukroun et al in 2001 used as a membrane could provide accelerated wound healing properties which would accelerate ginigival re-epithelization . Using a periodontal pack is conventionally used which will provide a mechanical barrier to protect the wound from any stimulus.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-eugenol containing periodontal packs with PRF | Experimental | Biological: PRF under non-eugenol containing periodontal packNon-eugenol containing periodontal packs with PRF after gingival de-pigmentation |
| Non-eugenol containing periodontal packs | Placebo comparator | Other: Non-eugenol containing periodontal packNon-eugenol containing periodontal packs after gingival de-pigmentation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Ages18-40 years old
- Systemically healthy
- Mild to moderate gingival pigmentations
- Gingival and plaque index <1
- Good oral hygiene
Key exclusion criteria (6 listed)
- Smokers
- Taking any medications that could affect healing
- Pervious depigmentation procedures
- Pregnant or lactating females
- Pervious periodontal surgery within the last 6 months before the start of the trial
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 |
|---|---|---|
| PRF under non-eugenol containing periodontal packAlso: Platelet Rich FibrinPlatelet Rich Fibrin under non-eugenol containing periodontal pack | Biological | Non-eugenol containing periodontal packs with PRF |
| Non-eugenol containing periodontal packNon-eugenol containing periodontal pack after gingival depigmentation | Other | Non-eugenol containing periodontal packs |
Primary outcome
Post-operative pain
Time frame: 1st day post-operative
Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
Post-operative pain
Time frame: 3rd day post-operative
Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
Post-operative pain
Time frame: 5th day post-operative
Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
4 secondary outcomes
Re-epithelization
Time frame: 5th day post-operative
Wound healing
Time frame: 3rd day post-operative
Wound healing
Time frame: 5th day post-operative
Re-pigmentation
Time frame: 6 months post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Background: PubMed 31367132Dahiya R, Blaggana A, Panwar V, Kumar S, Kathuria A, Malik S. Clinical and histological comparison of platelet-rich fibrin versus non-eugenol periodontal dressing in the treatment of gingival hyperpigmentation. J Indian Soc Periodontol. 2019 Jul-Aug;23(4):345-350. doi: 10.4103/jisp.jisp_688_18.
- Individual participant dataSharing planned: No
Related trials for Gingival Pigmentation
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Gingival Depigmentation Using a 940 nm Diode Laser Versus Ceramic Bur
Physiologic Gingival Melanin Pigmentation
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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
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RecruitingPhase 2
Gingival Hyperpigmentation Treatment
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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 Early Phase 1 study testing PRF under non-eugenol containing periodontal pack and Non-eugenol containing periodontal pack in people with Gingival Pigmentation, 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 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: status not confirmed, as of the sponsor's last update on 31 Jul 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 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. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 1st day post-operative). The study lists 3 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 NCT04495205, 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 31 Jul 2020.