Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03616197
Other study ID # 2016-9/7
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date July 2018

Study information

Verified date August 2018
Source Istanbul Aydin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the effect of mesial and distal adjacent gingival biotypes of the tooth / teeth region of free gingival graft (FGG) on the shrinkage ratio of graft at 6 months postoperatively.


Description:

The concept of gingival and periodontal phenotype was established as a result of clinical observation of changes in facial keratinized tissue width and thickness .It has been reported that gingival or periodontal diseases may develop more frequently in patients with thin gingival biotypes and that thick-flat biotype in implant restorations is important in achieving a successful aesthetic treatment outcome.

Free gingival graft (FGG) is a mucogingival surgical procedure that is successfully used in the presence of inadequate keratinized gingival width and gingival recession. It is thought that factors that may adversely affect the continuity of graft nutrition may be effective in graft shrinkage. These reasons can be listed as follows; graft thickness, traumatic surgical procedure, graft dehydration, and suturing procedure.

There was no study investigating the effect of periodontal biotypes on graft contraction in the region adjacent to the FGG operation.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 2018
Est. primary completion date April 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- In the mandibular incisor tooth / teeth, the attached keratinized gingival width is <1 mm,

- No periodontal surgery has been performed previously on the involved tooth.

- In the absence of any systemic condition or illness (pregnancy, breastfeeding, mental retardation, diabetes, etc.) that may interfere with the patient's approval and dental treatment.

- Do not use any of the drug groups that may cause gingival overgrowth.

Exclusion Criteria:

- Previous periodontal surgery in the operation area

- Restoration of the buccal surface of the tooth and no pathology in the apical region of the tooth.

- In the presence of any systemic condition or illness (pregnancy, breastfeeding, mental retardation, diabetes, etc.) that may interfere with the patient's approval and dental treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
free gingival graft
A horizontal incision was made along the mucogingival line with a scalpel number 15 to prepare a bed of periosteum and a thin immobilized connective tissue. The moving gingival tissues were removed coronally, and the bed was prepared so that the immobilized keratinized gingival tissue was preserved and the graft was placed apically. The template of the recipient region was placed in the donor region to be 2-3 mm more apically than the gingival margins of the teeth. The number of 15 scalpel was used to make incision at the template border and perpendicular to the keratinized tissue. The graft thickness was standardized in all patients between 1.5-2 mm. FGG was placed over the recipient bed and 5/0 non-resorbable monofilament sutures were used for fixing the four corners of the graft.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Aydin University

References & Publications (3)

Barbosa FI, Corrêa DS, Zenóbio EG, Costa FO, Shibli JA. Dimensional changes between free gingival grafts fixed with ethyl cyanoacrylate and silk sutures. J Int Acad Periodontol. 2009 Apr;11(2):170-6. — View Citation

Gümüs P, Buduneli E. Graft stabilization with cyanoacrylate decreases shrinkage of free gingival grafts. Aust Dent J. 2014 Mar;59(1):57-64. doi: 10.1111/adj.12149. Epub 2014 Feb 4. — View Citation

Hatipoglu H, Keçeli HG, Güncü GN, Sengün D, Tözüm TF. Vertical and horizontal dimensional evaluation of free gingival grafts in the anterior mandible: a case report series. Clin Oral Investig. 2007 Jun;11(2):107-13. Epub 2007 Feb 9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The graft shrinkage ratio Graft shrinkage = Preoperative area - Postoperative area X 100 Preoperative area baseline - 6th months postoperatively
Secondary keratinized ginigival width Keratinized Gingival Width(KGW) was measured using a lugol solution (10% potassium iodide and 5% iodine) with a manual caliper spaced 0.5 mm from the mid-buccal point of the tooth, the distance between the gingival margin and mucogingival junction from MTT, DTT and the teeth/tooth in operation area. baseline - 6th months postoperatively
See also
  Status Clinical Trial Phase
Completed NCT04462237 - Recombinant Human Platelet-derived Growth Factor in Combination With Collagen Matrix N/A
Enrolling by invitation NCT05591326 - The Effect of Using Injectable Platelet-rich Fibrin on Root Surface Closure in Patients With Gingival Recession. N/A
Completed NCT06118177 - Ultrasonographic Assessment of Palatal Wound Healing
Not yet recruiting NCT06044870 - Clinical Evaluation of the Modified Laterally Stretched Technique (RT2) Gingival Recession vs Tunneling With CT Grafting Phase 2
Recruiting NCT02995070 - Low Intensity Laser Therapy in Connective Tissue Graft for Root Coverage in Smokers N/A
Completed NCT03204565 - Effectiveness of Adjunctive Hyaluronic Acid Application in Coronally Advanced Flap in Single Gingival Recession Sites N/A
Completed NCT01440426 - Connective Tissue Graft Versus Mucograft Collagen Matrix for Coverage of Multiple Gingival Recession Defects Phase 4
Completed NCT02129504 - Two Techniques for Root Coverage With a Xenogeneic Collagen Matrix N/A
Completed NCT01547962 - A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva N/A
Completed NCT04043039 - Platelet Rich Fibrin in the Treatment of Full Thickness Palatal Wounds N/A
Recruiting NCT04920136 - Gain of Keratinized Mucosa Around Teeth and Dental Implants Using a Combination of Strip Gingival Graft and Acellular Dermal Matrix N/A
Active, not recruiting NCT03570333 - Progenitor Potential of Mesenchymal Stem Cells in Palatal Tissue Harvested From Molar and Premolar Sites N/A
Recruiting NCT05045586 - MCAT With HA and sCTG Compared With sCTG Alone for Treatment of Multiple Gingival Recession: Clinical Trial N/A
Active, not recruiting NCT05101642 - Guided Creeping Technique (GCT) in Treating Gingival Recession N/A
Completed NCT04813302 - Influence of Anatomical Factors Upon Root Coverage N/A
Recruiting NCT06006780 - Porcine Acellular Dermal Matrix for the Treatment of Localized Gingival Recessions A Multicenter Randomized Clinical Trial. N/A
Recruiting NCT06044727 - MINST Versus Conventional Subgingival Instrumentation In RT1 Gingival Recession N/A
Enrolling by invitation NCT06330662 - Effectiveness of Hyaluronic Acid on Multiple Adjacent Gingival Recessions Using a Coronally Advanced Flap N/A
Not yet recruiting NCT05472233 - Effect of Suturing Protocols on Coronally Advanced Flap for Root Coverage Outcomes N/A
Recruiting NCT05563428 - Free Gingival Graft Versus Connective Tissue Graft N/A