Lack of Keratinized GingivaNCT05287152
Titanium Tacked Soft Tissue Stabilization : A Novel Technique For Free Gingival Graft Fixation
A study testing titanium tacks or pins in people with Lack of Keratinized Gingiva, run by Egyptian Biomedical Research Network at 1 site in Egypt.
Trial summary
A case series study on ten patients with lack of keratinization in the non-esthetic area .the purpose of the study is the evaluation of using the titanium tacks in free gingival graft fixation as an alternative to the conventional suturing techniques or the tissue adhesives. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lack of Keratinized Gingiva
- What is being tested?
- titanium tacks or pins
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 2 Jan 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient with lack of keratinization in the non-esthetic areas
Who cannot join
- patients on chemotherapy
- patients on radiotherapy
- smokers
- patients with bad oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
A case series study on ten patients with lack of keratinization in the non-esthetic area .the purpose of the study is the evaluation of using the titanium tacks in free gingival graft fixation as an alternative to the conventional suturing techniques or the tissue adhesives.
Read the detailed description
A case series study conducted on 10 patients with lack of keratinization in the non- esthetic areas for clinical evaluation of the effeciancy of the titanium tacks in free gingival graft fixation in terms of the amount of the graft shrinkage through out a six months follow up period . the records will be taken through imagej software for comparing the graft surface area at 1 , 3 and six months .
- Conditions
- Lack of Keratinized Gingiva
- Being tested
- titanium tacks or pins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
titanium tacks or pinsDevice
using tacks or pins made of titanium 2.5 mm diameter and 4mm length for free gingival graft fixation.
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the amount of the free gingival graft contraction when being fixed using the titanium tacks( bone tacks)
evaluating the amount of graft contraction by a software standardized surface area calibration of digital photographs taken at one, three, and six months postoperatively
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Mar 2021
- Primary completion6 Dec 2021
- Study completion2 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lack of Keratinized GingivaStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Using the titanium tacks in free gingival graft fixation instead of conventional suturing.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Mohamed Khairy Mohammed Tammam, Egyptian Biomedical Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287152
- Sponsor's protocol ID
- free gingival graft fixation
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thoma DS, Naenni N, Figuero E, Hammerle CHF, Schwarz F, Jung RE, Sanz-Sanchez I. Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Mar;29 Suppl 15:32-49. doi: 10.1111/clr.13114.
PubMed 29498129Dragan IF, Hotlzman LP, Karimbux NY, Morin RA, Bassir SH. Clinical Outcomes of Comparing Soft Tissue Alternatives to Free Gingival Graft: A Systematic Review and Meta-Analysis . J Evid Based Dent Pract. 2017 Dec;17(4):370-380.e3. doi: 10.1016/j.jebdp.2017.05.008. Epub 2017 May 26.
PubMed 29197438Lim HC, An SC, Lee DW. A retrospective comparison of three modalities for vestibuloplasty in the posterior mandible: apically positioned flap only vs. free gingival graft vs. collagen matrix. Clin Oral Investig. 2018 Jun;22(5):2121-2128. doi: 10.1007/s00784-017-2320-y. Epub 2017 Dec 23.
PubMed 29275490Greenwell H, Fiorellini J, Giannobile W, Offenbacher S, Salkin L, Townsend C, Sheridan P, Genco R; Research, Science and Therapy Committee. Oral reconstructive and corrective considerations in periodontal therapy. J Periodontol. 2005 Sep;76(9):1588-600. doi: 10.1902/jop.2005.76.9.1588.
PubMed 16171452Korkis S, Thompson TN, Vizirakis MA, Lamble M, Zimmerman D, Neely AL, Kinaia BM. Stabilization Techniques for Soft Tissue Grafting Around Dental Implants: Case Report. Clin Adv Periodontics. 2019 Dec;9(4):192-195. doi: 10.1002/cap.10071. Epub 2019 Sep 23.
PubMed 31497932Shi Y, Segelnick SL, El Chaar ES. A Modified Technique of Tacking Acellular Dermal Matrix to Increase Keratinized Mucosa Around Dental Implants as an Alternative to a Free Gingival Graft: A Case Report. Clin Adv Periodontics. 2020 Dec;10(4):175-180. doi: 10.1002/cap.10113. Epub 2020 Aug 13.
PubMed 32692900
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titanium Tacked Soft Tissue Stabilization : A Novel Technique For Free Gingival Graft Fixation
- ClinicalTrials.gov ID
- NCT05287152
- Acronym / sponsor ID
- free gingival graft fixation
- Conditions
- Lack of Keratinized Gingiva
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 2 Jan 2022 (actual)
- First posted
- 18 Mar 2022 (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.
A case series study on ten patients with lack of keratinization in the non-esthetic area .the purpose of the study is the evaluation of using the titanium tacks in free gingival graft fixation as an alternative to the conventional suturing techniques or the tissue adhesives.
Detailed description
A case series study conducted on 10 patients with lack of keratinization in the non- esthetic areas for clinical evaluation of the effeciancy of the titanium tacks in free gingival graft fixation in terms of the amount of the graft shrinkage through out a six months follow up period . the records will be taken through imagej software for comparing the graft surface area at 1 , 3 and six months .
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Using the titanium tacks in free gingival graft fixation instead of conventional suturing.
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patient with lack of keratinization in the non-esthetic areas
Key exclusion criteria (4 listed)
- patients on chemotherapy
- patients on radiotherapy
- smokers
- patients with bad oral hygiene
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 |
|---|---|---|
| titanium tacks or pinsusing tacks or pins made of titanium 2.5 mm diameter and 4mm length for free gingival graft fixation. | Device | – |
Primary outcome
evaluation of the amount of the free gingival graft contraction when being fixed using the titanium tacks( bone tacks)
Time frame: 6 months
evaluating the amount of graft contraction by a software standardized surface area calibration of digital photographs taken at one, three, and six months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Results publication: PubMed 29498129Thoma DS, Naenni N, Figuero E, Hammerle CHF, Schwarz F, Jung RE, Sanz-Sanchez I. Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Mar;29 Suppl 15:32-49. doi: 10.1111/clr.13114.
- Results publication: PubMed 29197438Dragan IF, Hotlzman LP, Karimbux NY, Morin RA, Bassir SH. Clinical Outcomes of Comparing Soft Tissue Alternatives to Free Gingival Graft: A Systematic Review and Meta-Analysis . J Evid Based Dent Pract. 2017 Dec;17(4):370-380.e3. doi: 10.1016/j.jebdp.2017.05.008. Epub 2017 May 26.
- Results publication: PubMed 29275490Lim HC, An SC, Lee DW. A retrospective comparison of three modalities for vestibuloplasty in the posterior mandible: apically positioned flap only vs. free gingival graft vs. collagen matrix. Clin Oral Investig. 2018 Jun;22(5):2121-2128. doi: 10.1007/s00784-017-2320-y. Epub 2017 Dec 23.
- Results publication: PubMed 16171452Greenwell H, Fiorellini J, Giannobile W, Offenbacher S, Salkin L, Townsend C, Sheridan P, Genco R; Research, Science and Therapy Committee. Oral reconstructive and corrective considerations in periodontal therapy. J Periodontol. 2005 Sep;76(9):1588-600. doi: 10.1902/jop.2005.76.9.1588.
- Results publication: PubMed 31497932Korkis S, Thompson TN, Vizirakis MA, Lamble M, Zimmerman D, Neely AL, Kinaia BM. Stabilization Techniques for Soft Tissue Grafting Around Dental Implants: Case Report. Clin Adv Periodontics. 2019 Dec;9(4):192-195. doi: 10.1002/cap.10071. Epub 2019 Sep 23.
- Results publication: PubMed 32692900Shi Y, Segelnick SL, El Chaar ES. A Modified Technique of Tacking Acellular Dermal Matrix to Increase Keratinized Mucosa Around Dental Implants as an Alternative to a Free Gingival Graft: A Case Report. Clin Adv Periodontics. 2020 Dec;10(4):175-180. doi: 10.1002/cap.10113. Epub 2020 Aug 13.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing titanium tacks or pins in people with Lack of Keratinized Gingiva, run by Egyptian Biomedical Research Network 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 1 inclusion and 4 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 18 Mar 2022. 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. 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?
evaluation of the amount of the free gingival graft contraction when being fixed using the titanium tacks( bone tacks) (time frame: 6 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 NCT05287152, which also lists 6 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 18 Mar 2022.