Lack of Keratinized TissueNCT04099680
Free Gingival Grafts (FGGs) in Mandibular Posterior Sites
A study testing Partial thickness recipient bed, Full thickness recipient bed and Bone screw (FDA approved bone screw) in people with Lack of Keratinized Tissue, run by Ohio State University at 1 site in United States.
Trial summary
In this proposed study a novel technique that utilizes bone screws as an anchorage device will be used to facilitate suturing and ensure graft tissue immobilization on full thickness recipient bed preparation sites. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Lack of Keratinized Tissue
- What is being tested?
- Partial thickness recipient bed, Full thickness recipient bed and Bone screw (FDA approved bone screw)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2020to 15 Apr 2025
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •2nd and 3rd year residents at Division of Periodontology, The Ohio State University, in good standing.
Who cannot join
- Smokers or users of nicotine replacement products
- Patients with any history of soft tissue surgery (grafting) in the area to be treated
- Patients with contraindication for periodontal soft tissue surgery, including an anatomical location of mental nerve that may restrict preparation of 10x10mm recipient bed
- Patients with contraindication, e.g., allergy, for any of the medications used in the study (benzocaine, lidocaine, chlorhexidine rinse, ibuprofen)
- Patients with inadequate donor site anatomy.
- Patients with uncontrolled diabetes (glycemic level > 110mg/l and HbA1c > 6%)
Show all 19Show fewer
- Patients with drug or alcohol abuse
- Pregnant or lactating women
- Patients with a history of bisphosphonate therapy, radiotherapy in the head and neck region for malignancies, or chemotherapy for treatment of malignant tumors
- Other systemic conditions or medications affecting surgical or wound healing process and gingival tissues, such as cancer, HIV, metabolic bone diseases, phenytoin, cyclosporine, dihydropyridines, etc.
- <Dental>
- •Poor oral hygiene (PlI>2) 28
- Subjects will be exited from the study immediately upon:
- Change of mind regarding participation
- Development of acute dental/oral conditions requiring treatment
- Development of a condition requiring treatment that conflicts with the exclusion criteria listed above
- Failure to comply with study instructions/requirements/appointments
- Target population: Operators
- •Residents who don't want to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Dentistry
Columbus, Ohio, 43210
About this study
Official title: Free Gingival Grafts (FGGs) in Mandibular Posterior Sites: A Randomized Clinical Trials of Wound Healing Following Different Recipient Bed Preparations
In this proposed study a novel technique that utilizes bone screws as an anchorage device will be used to facilitate suturing and ensure graft tissue immobilization on full thickness recipient bed preparation sites. Currently, no information is available on free gingival graft treatment outcomes comparing full thickness recipient bed preparation, i.e., no periosteum remaining under the free gingival graft, with the aid of bone screws versus a conventional partial thickness recipient bed preparation with periosteum remaining under the graft. The purpose of the present study is to investigate the effect of these two different recipient bed preparations on soft tissue dimension change, graft and surgical wound healing, patient comfort, surgical complication frequency and operator satisfaction after free gingival graft to increase the width of keratinized gingival tissue in mandibular posterior sites. The purpose of the present study is to investigate the effect of these two different recipient bed preparations on soft tissue dimension change, graft and surgical wound healing, patient comfort, surgical complication frequency and operator satisfaction after free gingival graft procedure to increase the width of keratinized gingival tissue in mandibular posterior sites. The specific aims of this research study contain two aspects:
- To compare the wound healing of a free gingival graft using either a partial thickness flap or full-thickness flap preparation with bone screws at the recipient site around mandibular posterior areas.
- To assess patient comfort and surgeon satisfaction with a free gingival graft procedure using these two different recipient bed preparations.
Read the detailed description
While the presence of a sufficient size of keratinized oral mucosa is favorable, the surgical procedure to increase the size is technically difficult. In the traditional way, preparation of the gum bed for a graft tissue is done with partial-thickness flap elevation, in which part of the mucosa and submucosa, but not the periosteum (dense fibrous membrane covering the surface of bones), are separated from underneath bone. In the traditional method of gum bed preparation, separation of the mucosa and submucosa from underneath periosteum and bone should be done with extremely caution to avoid damaging the periosteum. Therefore, the traditional method of gum bed preparation is not only time consuming but also problematic because of more bleeding when compared to full thickness flap elevation, in which the mucosa and submucosa together with the periosteum are separated from underneath bone. In order to stabilize gum graft on bone surface, a new technique is applied in this study by using two bone screws as anchorage to fastened the graft on the exposed bone through suturing. In the present study, we will compare patient quality of life, operator satisfaction, and differences in surgical wound healing between these two different bed preparations. The results of this study could help establish a more patient- and operator-friendly surgical protocol for the use of gum graft to increase the width of keratinized oral mucosa.
- Conditions
- Lack of Keratinized Tissue
- Being tested
- Partial thickness recipient bed, Full thickness recipient bed, Bone screw (FDA approved bone screw), Periosteal sutures, Sling sutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial thickness recipient bedProcedure or surgery
Flap will be separated by sharp dissection and elevated toward apical direction, leaving the periosteum covering the bone, and the elevated pedicle flap will be incised and removed.
Full thickness recipient bedProcedure or surgery
Full-thickness (mucoperiosteal) flap will be raised on the recipient bed to establish a denuded bone area. Two bone screws will be placed at the most apical border of the denuded bone.
Bone screw (FDA approved bone screw)Device
Two bone screws placed at the most apical border of the denuded bone after osteotomy.
Periosteal suturesProcedure or surgery
Interrupted periosteal sutures placed at the 4 corners of each graft, and mesial and distal surfaces to engage the graft at an equidistance from the graft corners.
Sling suturesProcedure or surgery
Crossed sling sutures placed over the graft engaging the fixed crestal/lingual KT coronally and the periosteum apically.
Sling sutures around screwsProcedure or surgery
Crossed sling sutures placed over the graft engaging the fixed crestal/lingual KT coronally and each is apically looped around the corresponding apically positioned screw.
| Study group | Role | What they receive |
|---|---|---|
| Partial-thickness bed preparation | Active comparator | Partial-thickness bed preparation for free gingival graft procedure. Receives: Procedure: Partial thickness recipient bed; Procedure: Periosteal sutures; Procedure: Sling sutures |
| Full-thickness bed preparation | Experimental | Full-thickness bed preparation with bone screw placement for anchoring the sutures. Receives: Procedure: Full thickness recipient bed; Device: Bone screw (FDA approved bone screw); Procedure: Periosteal sutures; Procedure: Sling sutures around screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft width, length and area
Graft length and width will be confirmed after harvest and remeasured in situ, using a digital caliper, after completion of the surgical procedure. Subsequently, graft length and width will be measured on clinical images obtained at the post-op visits. A mirror image photo of the grafted site will be taken with a single-lens reflex camera and the dimension will be measured and analyzed with Image J software. Size markers will be used to calibrate image magnification. Graft area will be calculated from the length and width measurements.
Measured: During the surgery, at the 1-, 2-, 4-, 8- week visits
Secondary outcomes (8)
Wound healing index
Clinical photographs of the recipient sites will be taken at baseline, immediately after surgery, and at each follow-up visit, to record the appearance of the graft. A size marker will be used to standardize photos. Small size mirror will be placed with caution to avoid any disturbance of the surgical site, and mirror image photo will be taken. Wound healing index by Pippi et al. , which is the modified Wound Healing Index by Landry et al., is customized and used to evaluate the healing potential of the graft.
Measured: At the 3-day, 1-, 2-, 4-, 8- week visits
Graft thickness
Graft thickness will be measured in situ with digital caliper, and at the 8-week follow-up visit using an endodontic reamer, at five (5) predetermined points. A central point will be located at the geometric center of the graft, where the two diagonals of the square intersect. The other four points will each be located on the diagonal, at 3 mm from the corner of the graft. Pre-fabricated acrylic stent with holes for the measurements will be used to standardize measurement location. At 8 weeks, graft thickness measurements will be repeated following topical and local anesthesia using infiltration.
Measured: During the surgery, at the 8-week visits
Graft mobility
At the end of the procedure, graft mobility will be assessed indirectly and graded. While exerting tension on the cheek/vestibule, graft will be observed for mobility. Mobility will be graded indirectly, by exerting tension on the cheek/vestibule, and directly, by applying gentle force on the graft using a periodontal probe, in a manner similar to the functional approach used to locate the mucogingival junction.
Measured: At the end of surgery, at the 8-week visits
Biochemical wound assessment
Wound fluid will be collected from the transplanted graft site. Paper strips will be left in place for 30 sec and then immediately transferred to a micro-moisture meter to determine the volume of collected fluid. Following volume measurement, paper strips will be immediately placed into a vial, on ice; fluid collection will be repeated after 5 minutes. Then the vial with the 4 paper strips will be transferred to a -80˚C freezer until further analysis. Expression of angiogenesis biomarkers will be quantified with the use of a human angiogenesis custom array kit according to the manufacturer's protocol.
Measured: At the 3-day, 1-, 2- week visits
Surgical time
Length of surgery will be measured at the time the operator starts the first incision in the recipient bed and stopped when the last suture placement is placed. Bed preparation and graft placement will be independently timed to compare between procedures and with operator's opinion.
Measured: During the surgery
Pain assessment.
A visual analogue scale (VAS) will be used to measure daily pain intensity at each postoperative week. The self-reported degree of pain will be scored, with 0 defined as the absence of pain and 10 as the maximum tolerable level of pain. The intake of NSAIDs will be also recorded. .
Measured: At the 3-day, 1-, 2-, 4-, 8- week visits
OHIP-14
The oral health-related quality of life will be assessed by the Oral Health Impact Profile scale (OHIP-14). Participants will be asked how frequently they had experienced the impact on each category in OHIP-14 with a 5-point scale (from 0 to 4). The total score of OHIP-14 will be calculated by adding the sum of each category from 14 questions (total score ranges from 0 to 56 points). Higher scores imply a poorer oral health quality of life, whereas lower scores indicate a better one.
Measured: Right before the surgery and at the 3-day, 1-, 2-, 4-, 8- week visits
Operator-centered outcomes
Immediately after the surgery, operators will receive custom questionnaire to assess the difficulty of the surgery. Each step of the surgery will be categorized and will be marked with 10-point scale (from 0 to 10) based on the surgical difficulty and time management.
After completion of the 2-week post-op visit, operators will be asked to assess difficulty of screw removal (test group only).
Also, after each enrolled operator has conducted all allocated cases (2 cases of full-thickness flap group and 2 cases of partial-thickness flap group, possibly up to 1 year.), including all 2-week post-op visits, he/she will be asked to report their preference of procedure (control or test)
Measured: Immediately after the surgery, 2-week post-op visit and when an operator has conducted all allocated cases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start31 Dec 2020
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Lack of Keratinized TissueStudies of the same condition, open and under way.
- More trials run by Ohio State 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tatakis Dimitris, DDS, PhD, Study director, The Ohio State University Graduate Periodontics Program Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099680
- Sponsor's protocol ID
- fsafggrct2019
- Other IDs
- 2019H0350
- Status last verified
- Mar 2024
- First submitted
- 18 Sep 2019
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Thoma DS, Buranawat B, Hammerle CH, Held U, Jung RE. Efficacy of soft tissue augmentation around dental implants and in partially edentulous areas: a systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S77-91. doi: 10.1111/jcpe.12220.
PubMed 24641003Nabers JM. Free gingival grafts. Periodontics. 1966 Sep-Oct;4(5):243-5. No abstract available.
PubMed 5223124Sullivan HC, Atkins JH. Free autogenous gingival grafts. I. Principles of successful grafting. Periodontics. 1968 Jun;6(3):121-9. No abstract available.
PubMed 5240496Sullivan HC, Atkins JH. Free autogenous gingival grafts. 3. Utilization of grafts in the treatment of gingival recession. Periodontics. 1968 Aug;6(4):152-60. No abstract available.
PubMed 5243142Dorfman HS, Kennedy JE, Bird WC. Longitudinal evaluation of free autogenous gingival grafts. J Clin Periodontol. 1980 Aug;7(4):316-24. doi: 10.1111/j.1600-051x.1980.tb01974.x.
PubMed 6936409Dorfman HS, Kennedy JE, Bird WC. Longitudinal evaluation of free autogenous gingival grafts. A four year report. J Periodontol. 1982 Jun;53(6):349-52. doi: 10.1902/jop.1982.53.6.349.
PubMed 7050339Kennedy JE, Bird WC, Palcanis KG, Dorfman HS. A longitudinal evaluation of varying widths of attached gingiva. J Clin Periodontol. 1985 Sep;12(8):667-75. doi: 10.1111/j.1600-051x.1985.tb00938.x.
PubMed 3902907Lang NP, Loe H. The relationship between the width of keratinized gingiva and gingival health. J Periodontol. 1972 Oct;43(10):623-7. doi: 10.1902/jop.1972.43.10.623. No abstract available.
PubMed 4507712Miyasato M, Crigger M, Egelberg J. Gingival condition in areas of minimal and appreciable width of keratinized gingiva. J Clin Periodontol. 1977 Aug;4(3):200-9. doi: 10.1111/j.1600-051x.1977.tb02273.x.
PubMed 330574Scheyer ET, Sanz M, Dibart S, Greenwell H, John V, Kim DM, Langer L, Neiva R, Rasperini G. Periodontal soft tissue non-root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S73-6. doi: 10.1902/jop.2015.140377.
PubMed 25644301Gobbato L, Avila-Ortiz G, Sohrabi K, Wang CW, Karimbux N. The effect of keratinized mucosa width on peri-implant health: a systematic review. Int J Oral Maxillofac Implants. 2013 Nov-Dec;28(6):1536-45. doi: 10.11607/jomi.3244.
PubMed 24278922Brito C, Tenenbaum HC, Wong BK, Schmitt C, Nogueira-Filho G. Is keratinized mucosa indispensable to maintain peri-implant health? A systematic review of the literature. J Biomed Mater Res B Appl Biomater. 2014 Apr;102(3):643-50. doi: 10.1002/jbm.b.33042. Epub 2013 Oct 7.
PubMed 24124021Wennstrom JL, Bengazi F, Lekholm U. The influence of the masticatory mucosa on the peri-implant soft tissue condition. Clin Oral Implants Res. 1994 Mar;5(1):1-8. doi: 10.1034/j.1600-0501.1994.050101.x.
PubMed 8038340Adibrad M, Shahabuei M, Sahabi M. Significance of the width of keratinized mucosa on the health status of the supporting tissue around implants supporting overdentures. J Oral Implantol. 2009;35(5):232-7. doi: 10.1563/AAID-JOI-D-09-00035.1.
PubMed 19882819Martin W, Lewis E, Nicol A. Local risk factors for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:28-38.
PubMed 19885433
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Gingival Grafts (FGGs) in Mandibular Posterior Sites: A Randomized Clinical Trials of Wound Healing Following Different Recipient Bed Preparations
- ClinicalTrials.gov ID
- NCT04099680
- Acronym / sponsor ID
- fsafggrct2019
- Conditions
- Lack of Keratinized Tissue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 23 Sep 2019 (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 this proposed study a novel technique that utilizes bone screws as an anchorage device will be used to facilitate suturing and ensure graft tissue immobilization on full thickness recipient bed preparation sites. Currently, no information is available on free gingival graft treatment outcomes comparing full thickness recipient bed preparation, i.e., no periosteum remaining under the free gingival graft, with the aid of bone screws versus a conventional partial thickness recipient bed preparation with periosteum remaining under the graft. The purpose of the present study is to investigate the effect of these two different recipient bed preparations on soft tissue dimension change, graft and surgical wound healing, patient comfort, surgical complication frequency and operator satisfaction after free gingival graft to increase the width of keratinized gingival tissue in mandibular posterior sites. The purpose of the present study is to investigate the effect of these two different recipient bed preparations on soft tissue dimension change, graft and surgical wound healing, patient comfort, surgical complication frequency and operator satisfaction after free gingival graft procedure to increase the width of keratinized gingival tissue in mandibular posterior sites. The specific aims of this research study contain two aspects:
- To compare the wound healing of a free gingival graft using either a partial thickness flap or full-thickness flap preparation with bone screws at the recipient site around mandibular posterior areas.
- To assess patient comfort and surgeon satisfaction with a free gingival graft procedure using these two different recipient bed preparations.
Detailed description
While the presence of a sufficient size of keratinized oral mucosa is favorable, the surgical procedure to increase the size is technically difficult. In the traditional way, preparation of the gum bed for a graft tissue is done with partial-thickness flap elevation, in which part of the mucosa and submucosa, but not the periosteum (dense fibrous membrane covering the surface of bones), are separated from underneath bone. In the traditional method of gum bed preparation, separation of the mucosa and submucosa from underneath periosteum and bone should be done with extremely caution to avoid damaging the periosteum. Therefore, the traditional method of gum bed preparation is not only time consuming but also problematic because of more bleeding when compared to full thickness flap elevation, in which the mucosa and submucosa together with the periosteum are separated from underneath bone. In order to stabilize gum graft on bone surface, a new technique is applied in this study by using two bone screws as anchorage to fastened the graft on the exposed bone through suturing. In the present study, we will compare patient quality of life, operator satisfaction, and differences in surgical wound healing between these two different bed preparations. The results of this study could help establish a more patient- and operator-friendly surgical protocol for the use of gum graft to increase the width of keratinized oral mucosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial-thickness bed preparation | Active comparator | Procedure: Partial thickness recipient bed, Procedure: Periosteal sutures, Procedure: Sling suturesPartial-thickness bed preparation for free gingival graft procedure. |
| Full-thickness bed preparation | Experimental | Procedure: Full thickness recipient bed, Device: Bone screw (FDA approved bone screw), Procedure: Periosteal sutures, Procedure: Sling sutures around screwsFull-thickness bed preparation with bone screw placement for anchoring the sutures. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •2nd and 3rd year residents at Division of Periodontology, The Ohio State University, in good standing.
Key exclusion criteria (19 listed)
- Smokers or users of nicotine replacement products
- Patients with any history of soft tissue surgery (grafting) in the area to be treated
- Patients with contraindication for periodontal soft tissue surgery, including an anatomical location of mental nerve that may restrict preparation of 10x10mm recipient bed
- Patients with contraindication, e.g., allergy, for any of the medications used in the study (benzocaine, lidocaine, chlorhexidine rinse, ibuprofen)
- Patients with inadequate donor site anatomy.
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 |
|---|---|---|
| Partial thickness recipient bedFlap will be separated by sharp dissection and elevated toward apical direction, leaving the periosteum covering the bone, and the elevated pedicle flap will be incised and removed. | Procedure or surgery | Partial-thickness bed preparation |
| Full thickness recipient bedFull-thickness (mucoperiosteal) flap will be raised on the recipient bed to establish a denuded bone area. Two bone screws will be placed at the most apical border of the denuded bone. | Procedure or surgery | Full-thickness bed preparation |
| Bone screw (FDA approved bone screw)Two bone screws placed at the most apical border of the denuded bone after osteotomy. | Device | Full-thickness bed preparation |
| Periosteal suturesInterrupted periosteal sutures placed at the 4 corners of each graft, and mesial and distal surfaces to engage the graft at an equidistance from the graft corners. | Procedure or surgery | Full-thickness bed preparation, Partial-thickness bed preparation |
| Sling suturesCrossed sling sutures placed over the graft engaging the fixed crestal/lingual KT coronally and the periosteum apically. | Procedure or surgery | Partial-thickness bed preparation |
| Sling sutures around screwsCrossed sling sutures placed over the graft engaging the fixed crestal/lingual KT coronally and each is apically looped around the corresponding apically positioned screw. | Procedure or surgery | Full-thickness bed preparation |
Primary outcome
Graft width, length and area
Time frame: During the surgery, at the 1-, 2-, 4-, 8- week visits
Graft length and width will be confirmed after harvest and remeasured in situ, using a digital caliper, after completion of the surgical procedure. Subsequently, graft length and width will be measured on clinical images obtained at the post-op visits. A mirror image photo of the grafted site will be taken with a single-lens reflex camera and the dimension will be measured and analyzed with Image J software. Size markers will be used to calibrate image magnification. Graft area will be calculated from the length and width measurements.
8 secondary outcomes
Wound healing index
Time frame: At the 3-day, 1-, 2-, 4-, 8- week visits
Graft thickness
Time frame: During the surgery, at the 8-week visits
Graft mobility
Time frame: At the end of surgery, at the 8-week visits
Biochemical wound assessment
Time frame: At the 3-day, 1-, 2- week visits
Surgical time
Time frame: During the surgery
Pain assessment.
Time frame: At the 3-day, 1-, 2-, 4-, 8- week visits
OHIP-14
Time frame: Right before the surgery and at the 3-day, 1-, 2-, 4-, 8- week visits
Operator-centered outcomes
Time frame: Immediately after the surgery, 2-week post-op visit and when an operator has conducted all allocated cases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Background: PubMed 24641003Thoma DS, Buranawat B, Hammerle CH, Held U, Jung RE. Efficacy of soft tissue augmentation around dental implants and in partially edentulous areas: a systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S77-91. doi: 10.1111/jcpe.12220.
- Background: PubMed 5223124Nabers JM. Free gingival grafts. Periodontics. 1966 Sep-Oct;4(5):243-5. No abstract available.
- Background: PubMed 5240496Sullivan HC, Atkins JH. Free autogenous gingival grafts. I. Principles of successful grafting. Periodontics. 1968 Jun;6(3):121-9. No abstract available.
- Background: PubMed 5243142Sullivan HC, Atkins JH. Free autogenous gingival grafts. 3. Utilization of grafts in the treatment of gingival recession. Periodontics. 1968 Aug;6(4):152-60. No abstract available.
- Background: PubMed 6936409Dorfman HS, Kennedy JE, Bird WC. Longitudinal evaluation of free autogenous gingival grafts. J Clin Periodontol. 1980 Aug;7(4):316-24. doi: 10.1111/j.1600-051x.1980.tb01974.x.
- Background: PubMed 7050339Dorfman HS, Kennedy JE, Bird WC. Longitudinal evaluation of free autogenous gingival grafts. A four year report. J Periodontol. 1982 Jun;53(6):349-52. doi: 10.1902/jop.1982.53.6.349.
- Background: PubMed 3902907Kennedy JE, Bird WC, Palcanis KG, Dorfman HS. A longitudinal evaluation of varying widths of attached gingiva. J Clin Periodontol. 1985 Sep;12(8):667-75. doi: 10.1111/j.1600-051x.1985.tb00938.x.
- Background: PubMed 4507712Lang NP, Loe H. The relationship between the width of keratinized gingiva and gingival health. J Periodontol. 1972 Oct;43(10):623-7. doi: 10.1902/jop.1972.43.10.623. No abstract available.
- Background: PubMed 330574Miyasato M, Crigger M, Egelberg J. Gingival condition in areas of minimal and appreciable width of keratinized gingiva. J Clin Periodontol. 1977 Aug;4(3):200-9. doi: 10.1111/j.1600-051x.1977.tb02273.x.
- Background: PubMed 25644301Scheyer ET, Sanz M, Dibart S, Greenwell H, John V, Kim DM, Langer L, Neiva R, Rasperini G. Periodontal soft tissue non-root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S73-6. doi: 10.1902/jop.2015.140377.
- Background: PubMed 24278922Gobbato L, Avila-Ortiz G, Sohrabi K, Wang CW, Karimbux N. The effect of keratinized mucosa width on peri-implant health: a systematic review. Int J Oral Maxillofac Implants. 2013 Nov-Dec;28(6):1536-45. doi: 10.11607/jomi.3244.
- Background: PubMed 24124021Brito C, Tenenbaum HC, Wong BK, Schmitt C, Nogueira-Filho G. Is keratinized mucosa indispensable to maintain peri-implant health? A systematic review of the literature. J Biomed Mater Res B Appl Biomater. 2014 Apr;102(3):643-50. doi: 10.1002/jbm.b.33042. Epub 2013 Oct 7.
- Individual participant dataSharing planned: No
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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.
Tatakis Dimitris, DDS, PhD study director
The Ohio State University Graduate Periodontics Program Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial thickness recipient bed, Full thickness recipient bed and Bone screw (FDA approved bone screw) in people with Lack of Keratinized Tissue, run by Ohio State University at 1 site in United States.
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 1 inclusion and 19 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 10 May 2024. 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 United States. 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?
Results are not available in the source record.
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?
Graft width, length and area (time frame: During the surgery, at the 1-, 2-, 4-, 8- week visits). 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 NCT04099680, which also lists 32 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 10 May 2024.