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Gingival RecessionNCT04248049

Platelet Rich Fibrin on Root Coverage of Gingival Recessions

A study testing Platelet rich fibrin in people with Gingival Recession, run by Universidad Antonio Nariño at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Several surgical techniques and various adjunctive agents have been used to covered Gingival Recession (GR) and promote clinical outcomes. The treatment of the GR more used (gold standard) is the root coverage with surgical procedures and connective tissue graft, but it has limitations due to the conditions of the… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
Platelet rich fibrin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteColombia
Study dates
1 Jan 2018to 30 Nov 2019
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participant is willing and able to give informed consent for participation in the study
  • Healthy males and females of age 18-60 years old
  • Multiple bilateral (maxillary or mandibular) gingival recessions (Miller class І or II)
  • Good oral hygiene (O´Leary index ≤ 15%)

Who cannot join

  • Active periodontal disease
  • Periodontal surgeries in the last three years
  • Pregnancy or lactation
  • Smokers or alcoholics
  • Platelet dysfunction syndrome or thrombocytopenia
  • Coagulation defects
Show all 15Show fewer
  • Uncontrolled diabetes
  • Medical contraindications to elective oral surgery procedures
  • Severe immunodeficiencies
  • Oncological history
  • Prosthetic restorations adjacent to gingival recessions
  • Mobility II or III
  • Occlusal contacts excessive
  • Root caries
  • Buccal restaurations Class V

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Universidad Antonio Nariño

    Bogotá, 110231

Other trials in Colombia

About this study

Official title: Clinical Evaluation of Coronal Advanced Flap and Platelet Rich Fibrin on Root Coverage of Gingival Recessions Over a Period of 24 Month.

Several surgical techniques and various adjunctive agents have been used to covered Gingival Recession (GR) and promote clinical outcomes. The treatment of the GR more used (gold standard) is the root coverage with surgical procedures and connective tissue graft, but it has limitations due to the conditions of the donor graft. Is necessary develop other biomaterials for these cases.

The platelet rich fibrin is a autologous biomaterial that has gained tremendous momentum having been utilized for a variety of dental and medical procedures including periodontal surgeries. However, results remain contradictory and mainly focus on the hard and soft tissue healing, aesthetics and postoperative discomfort.

The objective of this study was to evaluate the clinical effects of coronal advanced flap (CAF) and CAF + Platelet Rich Fibrin (PRF) on Root coverage (RC) over a period of 24 month.

Being tested
Platelet rich fibrin
Keywords
platelet-rich fibrin, platelet concentrates, periodontal diseases
Medical subject headings
Gingival Recession, Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Platelet rich fibrinOther

    The roots of patients with diagnosis of gingival recessions will be covered with coronally advanced flap (CAF) and platelet rich fibrin (PRF) (CAF+PRF)

Study groups in NCT04248049
Study groupRoleWhat they receive
Experimental sideExperimentalRoots covered with coronally advanced flap (CAF) and platelet rich fibrin (PRF) (CAF+PRF)
Receives: Other: Platelet rich fibrin
Control sideActive comparatorRoots covered with coronally advanced flap (CAR)
Receives: Other: Platelet rich fibrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of percentage of root coverage (PRC) from baseline at 12 and 24 months

    Complete root coverage after surgical correction measured in percentage by using periodontal probe.

    PRC= Preoperative recession depth - Postoperative recession depth X 100 % Preoperative recession depth

    Measured: baseline, 1, 3 , 6, 9, 12 and 24 months

Secondary outcomes (9)

  1. Vertical gingival recession (VGR)

    It is measuring the distance from the cemento-enamel junction (CEJ) to the margin of the gingiva at the midbuccal point of the teeth (measured using a periodontal probe in millimeters).

    Measured: baseline, 1, 3 , 6, 9, 12 and 24 months

  2. Horizontal gingival recession (HGR)

    Measured horizontally between two borders of the recession. (measured using a periodontal probe in millimeters).

    Measured: baseline, 1, 3 , 6, 9, 12 and 24 months

  3. Probing depth (PD)

    It is measuring the distance from the gingival margin to the base of the pocket using periodontal probe. The probe will be inserted parallel to the long axis of the tooth using light force. (measured using a periodontal probe in millimeters).

    Measured: baseline, 1, 3 , 6, 9, 12 and 24 months

  4. Clinical attachment level(CAL)

    Two measurements will be used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ.

    Measured: baseline, 1, 3 , 6, 9, 12 and 24 months

  5. Gingival tissue thickness

    The gingiva mid-buccally in the attached gingiva will be penetrated with an endodontic reamer with a silicon disc stop. The measure of penetration will be measured with dentimeter (mm).

    Measured: baseline, 1, 3 , 6, 9, 12 and 24 months

  6. Keratinized tissue height (KTH)

    To measure the tissue thickness, a guiding device will be made to standardize the region to be measured and then, at a specific point, the mucosa will be punctured with an endodontic spacer and the thickness marked with a rubber marker. Then, using a digital caliper, the thickness will be measured.

    Measured: baseline, 1, 3 , 6, 9, 12 and 24 months

  7. Gingival bleeding index (IS)

    Evaluation of the presence and absence of bleeding in the gingival margin through the gingival sulcus. The index is calculated after penetration of the sulcus by the periodontal probe, bleeding surfaces are noted and then counted. The index is calculated by dividing the number of surfaces that bleed by the total number of teeth and then multiplying by 100 to reach the percentage of bleeding index.

    Measured: baseline, 1, 3 , 6, 9, 12 and 24 months

  8. Visual analog scale (VAS)

    Visual analog scale

    Measured: baseline, 1, 3 , 6, 9, 12 and 24 months

  9. Evaluation of oral health impact on quality of life, using the Oral Health Impact Profile (OHIP-14) questionnaire.

    Evaluate the impact of oral health on patient's quality of life before and 1 year after implant installation. This evaluation will be carried out through the application of a questionnaire with 14 questions (Oral Health Impact Profile: OHIP-14) that assess the patient's perception regarding the impact of oral conditions on their well-being

    Measured: baseline, 1, 3 , 6, 9, 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2020
  2. Study start1 Jan 2018
  3. Primary completion30 Aug 2019
  4. Study completion30 Nov 2019

Resources

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
Model description
Randomized clinical trial (RCT) (Interventional)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04248049
Sponsor's protocol ID
Universidad Antonio Nariño
Status last verified
Jan 2020
First submitted
4 Sep 2019
Last updated
30 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li R, Liu Y, Xu T, Zhao H, Hou J, Wu Y, Zhang D. The Additional Effect of Autologous Platelet Concentrates to Coronally Advanced Flap in the Treatment of Gingival Recessions: A Systematic Review and Meta-Analysis. Biomed Res Int. 2019 Jul 25;2019:2587245. doi: 10.1155/2019/2587245. eCollection 2019.

    PubMed 31428630

  • Debnath K, Chatterjee A. Evaluation of periosteum eversion and coronally advanced flap techniques in the treatment of isolated Miller's Class I/II gingival recession: A comparative clinical study. J Indian Soc Periodontol. 2018 Mar-Apr;22(2):140-149. doi: 10.4103/jisp.jisp_5_18.

    PubMed 29769769

  • Mufti S, Dadawala SM, Patel P, Shah M, Dave DH. Comparative Evaluation of Platelet-Rich Fibrin with Connective Tissue Grafts in the Treatment of Miller's Class I Gingival Recessions. Contemp Clin Dent. 2017 Oct-Dec;8(4):531-537. doi: 10.4103/ccd.ccd_325_17.

    PubMed 29326502

  • Miron RJ, Zucchelli G, Pikos MA, Salama M, Lee S, Guillemette V, Fujioka-Kobayashi M, Bishara M, Zhang Y, Wang HL, Chandad F, Nacopoulos C, Simonpieri A, Aalam AA, Felice P, Sammartino G, Ghanaati S, Hernandez MA, Choukroun J. Use of platelet-rich fibrin in regenerative dentistry: a systematic review. Clin Oral Investig. 2017 Jul;21(6):1913-1927. doi: 10.1007/s00784-017-2133-z. Epub 2017 May 27.

    PubMed 28551729

Questions about this trial

What is this clinical trial studying?

A study testing Platelet rich fibrin in people with Gingival Recession, run by Universidad Antonio Nariño at 1 site in Colombia.

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 15 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 30 Jan 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 Colombia. 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?

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?

Change of percentage of root coverage (PRC) from baseline at 12 and 24 months (time frame: baseline, 1, 3 , 6, 9, 12 and 24 months). 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 NCT04248049, which also lists 4 linked publications.

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 30 Jan 2020.

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