Different Platelet Concentrates After Gingivectomy and Gingivoplasty Evaluation of Its Effect on Early Wound Healing.

NCT04805463 | Completed

• 1 other identifier: 2019/216
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the effect of PRF, CGF and AFG application on early wound healing after gingivectomy and gingivoplasty operations. In the study designed split mouth, gingivectomy and gingivoplasty surgery were performed on 19 patients. The postoperative PRF, CGF, and AFG applied areas were compared with the control regions. 0th,7 th,14 th and 28 th on the days, the surgical area was painted with mira-2-tone solution and evaluated in the ImageJ program. Measurements of clinical periodontal parameters including PI, GI, SC and SD were recorded at the beginning, after IPT and 28 days after the operation. Wound healing was evaluated with H2O2 test, VAS-Pain, and LTH index on 7th, 14th and 28th days. The patients were asked to evaluate their aesthetic perceptions on the VAS aesthetic scale.

Conditions

Wound Heal; Gingival Overgrowth; Gingival Enlargement; Platelet Rich Fibrin

Keywords

Autologous fibrin glue; Concentrated growth factor; Gingivectomy; Gingivoplasty; Platelet rich fibrin

Outcome Measures

Primary Outcomes (4)

• Determination of non-epithelialized areas on the wound surface

  Mira-2 tone solution was used to identify non-epithelialized areas on wound surfaces after gingivectomy and gingivoplasty. Mira-2 tone was applied to the wound surfaces and dark dyed areas were calculated as mm2 in Image j program.

  Postoperative 0, 7, 14 and 28 days, the change of the stained area with the mira-2 tone in the wound surface area was recorded.

• Epithelialization test

  H2O2 was used to identify non-epithelialized areas. If bubbling is observed after the application of H202 to the wound surface, epithelialization was incomplete, if bubbling was not observed, epithelialization was recorded as completed.

  The change in wound surface epithelization was evaluated on the 7th, 14th and 28th days postoperatively.

• Healing index

  Landry, Turnbull, Howley (LTH) index, which classified the healing process according to wound surface redness, presence of bleeding, granulation tissue, epithelization, and suppuration, was evaluated.

  Wound healing evaluation with LTH index was performed at the postoperative 7th, 14th and 28th day controls.

• Postoperative pain

  VAS was used for postoperative pain assessment. The patients were asked to evaluate the level of pain from 1 to 10 according to the VAS-Pain (1: low pain, 10: severe pain) scale during the control sessions.

  Evaluation of VAS-Pain change on postoperative 7th, 14th and 28th days.

Study Arms (4)

control group

EXPERIMENTAL

After gingivectomy and released into the secondary wound healing gingivoplasty group.

Other: Control group

PRF group

EXPERIMENTAL

The group in which PRF was applied to the wound surface after gingivectomy and gingivoplasty.

Other: PRF group

CGF group

EXPERIMENTAL

The group in which CGF was applied to the wound surface after gingivectomy and gingivoplasty.

Other: CGF group

AFG group

EXPERIMENTAL

The group in which AFG was applied to the wound surface after gingivectomy and gingivoplasty.

Other: AFG group

Interventions

Control group OTHER

The group that did not undergo any procedure after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied to the wound area.

control group

PRF group OTHER

The group in which PRF is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA)was applied over the PRF.

PRF group

CGF group OTHER

The group in which CGF is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied over the CGF.

CGF group

AFG group OTHER

The group in which AFG is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied over the AFG.

AFG group

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are systemically healthy, have chronic inflammatory gingival enlargement in the maxillary and mandibular anterior region, and who do not have attachments and bone loss in clinical and radiographic evaluation.

You may not qualify if:

• Patients with a history of periodontal treatment in the last 6 months, smokers, those using drugs that may cause gingival enlargement, and pregnant or breastfeeding women were excluded.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Department of Periodontology, Faculty of Dentistry, Inonu University

Malatya, Battalgazi, 44280, Turkey (Türkiye)

Location

Related Publications (9)

• Miranda J, Brunet L, Roset P, Berini L, Farre M, Mendieta C. Prevalence and risk of gingival enlargement in patients treated with nifedipine. J Periodontol. 2001 May;72(5):605-11. doi: 10.1902/jop.2001.72.5.605.

  PMID: 11394395 BACKGROUND

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 BACKGROUND

• Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.

  PMID: 16504850 BACKGROUND

• Rodella LF, Favero G, Boninsegna R, Buffoli B, Labanca M, Scari G, Sacco L, Batani T, Rezzani R. Growth factors, CD34 positive cells, and fibrin network analysis in concentrated growth factors fraction. Microsc Res Tech. 2011 Aug;74(8):772-7. doi: 10.1002/jemt.20968.

  PMID: 21780251 BACKGROUND

• Sohn D-S, Huang B, Kim J, Park WE, Park CC. Utilization of autologous concentrated growth factors (CGF) enriched bone graft matrix (Sticky bone) and CGF-enriched fibrin membrane in Implant Dentistry. J Implant Adv Clin Dent. 2015;7:11-29.

  BACKGROUND

• Landry RG. Effectiveness of Benzydamine HC1 in the Treatment of Periodontal Post-surgical Patients: Faculty of Dentistry, University of Toronto; 1985.

  BACKGROUND

• Crichton N. Visual analogue scale (VAS). J Clin Nurs. 2001;10(5):706-6

  BACKGROUND

• Miller CS, Damm DD. Incidence of verapamil-induced gingival hyperplasia in a dental population. J Periodontol. 1992 May;63(5):453-6. doi: 10.1902/jop.1992.63.5.453.

  PMID: 1527689 RESULT

MeSH Terms

Conditions

Gingival Overgrowth; Gingival Hyperplasia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RA

Model Details: Split mouth design was used in the study. The chin was divided into lower, upper and right, and left anterior regions. The distribution of the platelet concentrate and control group to be used after gingivectomy and gingivoplasty was randomly decided.

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: January 1, 2020
• Primary Completion: April 30, 2020
• Study Completion: May 30, 2020
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)