Dental ImplantsNCT06065254
Efficacy of Gingival Grafts During the Implantation Process on the Peri-implant Mucosa
A study testing Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness, Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness and No types of grafts will be made to improve the quality of the peri-implant mucosa in people with Dental Implants and Transplants, run by Damascus University at 1 site in Syria.
Trial summary
This study aims to compare the changes in the peri-implant mucosa during the application of two soft tissue grafting methods, which are free gingival graft (FGG) and connective tissue graft (CTG) taken from the palatine in terms of the width of the keratinized mucosa and the thickness of the peri-implant soft tissues. Read more about this study
- Who is it for?
- Ages 21 to 83 years
- Conditions the study is for
- Dental Implants, Transplants
- What is being tested?
- Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness, Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness and No types of grafts will be made to improve the quality of the peri-implant mucosa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSyria
- Study dates
- 10 May 2022to 25 Aug 2023
- 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 21 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who have lost posterior teeth (premolars or molars).
- A decrease in the amount of keratinized gingiva (less than 2 mm from the alveolar process to the mucogingival junction).
- good oral health (plaque index ≤1).
Who cannot join
- heavy smokers (more than 10 cigarettes per day)
- uncontrolled diabetes or other systemic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Gingival Grafts During the Implantation Process in the Increasing of Peri-implant Keratinized Tissue Width and Soft Tissues Thickness
This study aims to compare the changes in the peri-implant mucosa during the application of two soft tissue grafting methods, which are free gingival graft (FGG) and connective tissue graft (CTG) taken from the palatine in terms of the width of the keratinized mucosa and the thickness of the peri-implant soft tissues.
Read the detailed description
The presence of adequate width of the keratinized gingiva may be necessary in some special cases such as the presence of fixed prostheses on the teeth with sublingual margins or peri implants. There is an association between insufficiency of the keratinized tissues peri implants with greater plaque accumulation, signs of inflammation, soft tissue recession, and loss of attachment. The sample will consist of 33 dental implant sites and divide randomly into three groups: Group I (Experiential, n=11): FGG; Group II: (Experiential, n=11): CTG; and Group III: (Control, n=11): No procedure will be done to improve the quality of the peri-implant tissues. The width of the keratinized gingiva will be measured preoperative with a UNC-15 and the thickness of the peri-implant soft tissues will be measured clinically by direct transgingival propping method. These measurements will be repeated after 1 and 3 months.
- Conditions
- Dental Implants, Transplants
- Being tested
- Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness, Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness, No types of grafts will be made to improve the quality of the peri-implant mucosa
- Keywords
- Keratinized Mucosa, Connective Tissue Graft, Free Gingival Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thicknessOther
Two vertical incisions will be made in the previously elevated flap against the placed implant , where these two incisions will be 10 mm apart from each other, and the free graft to will be placed in this distance (10 x 10 mm). The graft will be obtained from the donor site (the hard palate), and will be thinned to obtain a regular graft with the required thickness. After that, the graft will be moved to its correct place accurately, while avoiding leaving a distance between the graft and the tissue underneath, and the graft will be sutured well to ensure its stability and correct placement.
Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thicknessOther
Vertical incisions will not be made in the previously elevated flap against the placed implant, where there is no need to suture the flap apically of the grafting place because the graft will be covered with it after fixing it in place. The area will be washed with the serum to remove the clot before fixing the graft.The graft will be obtained from the donor site according to the previously mentioned method. Then the epithelium will be removed to leave the connective tissue underneath, and then the graft will be moved to its place (buccally dental implant site) and the flap will be sutured over it.
No types of grafts will be made to improve the quality of the peri-implant mucosaOther
The simple suturing of the two surgical incisions will be done after the completion of the dental implant process, with no procedure will be made to improve the quality of the peri-implant mucosa.
| Study group | Role | What they receive |
|---|---|---|
| Free gingival graft | Experimental | Free gingival graft will be applied and and followed for 3 months Receives: Other: Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness |
| Connective tissue graft | Experimental | Connective tissue graft will be applied and and followed for 3 months Receives: Other: Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness |
| No grafts will be applied. | Other | No grafts of any types will be applied. Receives: Other: No types of grafts will be made to improve the quality of the peri-implant mucosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
The width of the keratinized gingiva
The width of the keratinized gingiva will be measured using a UNC-15 probe from the middle of the alveolar process at the site studied to the mucogingival junction, which was determined by the rollover technique.
Measured: after 1 month and 3 months
The thickness of the peri-implant soft tissues
The thickness of the peri-implant soft tissues will be measured clinically by the direct transgingival propping method.
Measured: after 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start10 May 2022
- Primary completion14 Feb 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmad Alshouaa, MSc, Principal investigator, MSc student in Periodontology Departement, University of DamascusMohammed Alsabbagh, Study chair, Professor of Periodontology, Department of Periodontology, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065254
- Sponsor's protocol ID
- UDDS-Perio-01-2023
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Angelis P, De Angelis S, Passarelli PC, Liguori MG, Pompa G, Papi P, Manicone PF, D'Addona A. Clinical comparison of a xenogeneic collagen matrix versus subepithelial autogenous connective tissue graft for augmentation of soft tissue around implants. Int J Oral Maxillofac Surg. 2021 Jul;50(7):956-963. doi: 10.1016/j.ijom.2020.11.014. Epub 2020 Dec 2.
PubMed 33279377Schmitt CM, Bruckbauer P, Schlegel KA, Buchbender M, Adler W, Matta RE. Volumetric soft tissue alterations in the early healing phase after peri- implant soft tissue contour augmentation with a porcine collagen matrix versus the autologous connective tissue graft: A controlled clinical trial. J Clin Periodontol. 2021 Jan;48(1):145-162. doi: 10.1111/jcpe.13387. Epub 2020 Nov 12.
PubMed 33047372Raoofi S, Asadinejad SM, Khorshidi H. Evaluation of Color and Width of Attached Gingiva Gain in Two Surgical Techniques: Free Gingival Graft and Connective Tissue Graft Covered By Thin Mucosal Flap, a Clinical Trial. J Dent (Shiraz). 2019 Dec;20(4):224-231. doi: 10.30476/DENTJODS.2019.44916.
PubMed 31875168Happe A, Stimmelmayr M, Schlee M, Rothamel D. Surgical management of peri-implant soft tissue color mismatch caused by shine-through effects of restorative materials: one-year follow-up. Int J Periodontics Restorative Dent. 2013 Jan-Feb;33(1):81-8. doi: 10.11607/prd.1344.
PubMed 23342350Thoma 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 24641003
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Gingival Grafts During the Implantation Process in the Increasing of Peri-implant Keratinized Tissue Width and Soft Tissues Thickness
- ClinicalTrials.gov ID
- NCT06065254
- Acronym / sponsor ID
- UDDS-Perio-01-2023
- Conditions
- Dental Implants, Transplants
- Keywords
- Keratinized Mucosa, Connective Tissue Graft, Free Gingival Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 3 Oct 2023 (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.
This study aims to compare the changes in the peri-implant mucosa during the application of two soft tissue grafting methods, which are free gingival graft (FGG) and connective tissue graft (CTG) taken from the palatine in terms of the width of the keratinized mucosa and the thickness of the peri-implant soft tissues.
Detailed description
The presence of adequate width of the keratinized gingiva may be necessary in some special cases such as the presence of fixed prostheses on the teeth with sublingual margins or peri implants. There is an association between insufficiency of the keratinized tissues peri implants with greater plaque accumulation, signs of inflammation, soft tissue recession, and loss of attachment. The sample will consist of 33 dental implant sites and divide randomly into three groups: Group I (Experiential, n=11): FGG; Group II: (Experiential, n=11): CTG; and Group III: (Control, n=11): No procedure will be done to improve the quality of the peri-implant tissues. The width of the keratinized gingiva will be measured preoperative with a UNC-15 and the thickness of the peri-implant soft tissues will be measured clinically by direct transgingival propping method. These measurements will be repeated after 1 and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Free gingival graft | Experimental | Other: Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thicknessFree gingival graft will be applied and and followed for 3 months |
| Connective tissue graft | Experimental | Other: Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thicknessConnective tissue graft will be applied and and followed for 3 months |
| No grafts will be applied. | Other | Other: No types of grafts will be made to improve the quality of the peri-implant mucosaNo grafts of any types will be applied. |
Who may qualify
- Ages
- 21 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who have lost posterior teeth (premolars or molars).
- A decrease in the amount of keratinized gingiva (less than 2 mm from the alveolar process to the mucogingival junction).
- good oral health (plaque index ≤1).
Key exclusion criteria (2 listed)
- heavy smokers (more than 10 cigarettes per day)
- uncontrolled diabetes or other systemic diseases.
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 |
|---|---|---|
| Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thicknessTwo vertical incisions will be made in the previously elevated flap against the placed implant , where these two incisions will be 10 mm apart from each other, and the free graft to will be placed in this distance (10 x 10 mm). The graft will be obtained from the donor site (the hard palate), and will be thinned to obtain a regular graft with the required thickness. After that, the graft will be moved to its correct place accurately, while avoiding leaving a distance between the graft and the tissue underneath, and the graft will be sutured well to ensure its stability and correct placement. | Other | Free gingival graft |
| Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thicknessVertical incisions will not be made in the previously elevated flap against the placed implant, where there is no need to suture the flap apically of the grafting place because the graft will be covered with it after fixing it in place. The area will be washed with the serum to remove the clot before fixing the graft.The graft will be obtained from the donor site according to the previously mentioned method. Then the epithelium will be removed to leave the connective tissue underneath, and then the graft will be moved to its place (buccally dental implant site) and the flap will be sutured over it. | Other | Connective tissue graft |
| No types of grafts will be made to improve the quality of the peri-implant mucosaThe simple suturing of the two surgical incisions will be done after the completion of the dental implant process, with no procedure will be made to improve the quality of the peri-implant mucosa. | Other | No grafts will be applied. |
Primary outcome
The width of the keratinized gingiva
Time frame: after 1 month and 3 months
The width of the keratinized gingiva will be measured using a UNC-15 probe from the middle of the alveolar process at the site studied to the mucogingival junction, which was determined by the rollover technique.
The thickness of the peri-implant soft tissues
Time frame: after 1 month and 3 months
The thickness of the peri-implant soft tissues will be measured clinically by the direct transgingival propping method.
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 3 Oct 2023.
- Background: PubMed 33279377De Angelis P, De Angelis S, Passarelli PC, Liguori MG, Pompa G, Papi P, Manicone PF, D'Addona A. Clinical comparison of a xenogeneic collagen matrix versus subepithelial autogenous connective tissue graft for augmentation of soft tissue around implants. Int J Oral Maxillofac Surg. 2021 Jul;50(7):956-963. doi: 10.1016/j.ijom.2020.11.014. Epub 2020 Dec 2.
- Background: PubMed 33047372Schmitt CM, Bruckbauer P, Schlegel KA, Buchbender M, Adler W, Matta RE. Volumetric soft tissue alterations in the early healing phase after peri- implant soft tissue contour augmentation with a porcine collagen matrix versus the autologous connective tissue graft: A controlled clinical trial. J Clin Periodontol. 2021 Jan;48(1):145-162. doi: 10.1111/jcpe.13387. Epub 2020 Nov 12.
- Background: PubMed 31875168Raoofi S, Asadinejad SM, Khorshidi H. Evaluation of Color and Width of Attached Gingiva Gain in Two Surgical Techniques: Free Gingival Graft and Connective Tissue Graft Covered By Thin Mucosal Flap, a Clinical Trial. J Dent (Shiraz). 2019 Dec;20(4):224-231. doi: 10.30476/DENTJODS.2019.44916.
- Background: PubMed 23342350Happe A, Stimmelmayr M, Schlee M, Rothamel D. Surgical management of peri-implant soft tissue color mismatch caused by shine-through effects of restorative materials: one-year follow-up. Int J Periodontics Restorative Dent. 2013 Jan-Feb;33(1):81-8. doi: 10.11607/prd.1344.
- 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.
- 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.
Ahmad Alshouaa, MSc principal investigator
MSc student in Periodontology Departement, University of Damascus
Mohammed Alsabbagh study chair
Professor of Periodontology, Department of Periodontology, University of Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness, Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness and No types of grafts will be made to improve the quality of the peri-implant mucosa in people with Dental Implants and Transplants, run by Damascus University at 1 site in Syria.
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 3 inclusion and 2 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 3 Oct 2023. 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 Syria. 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?
The width of the keratinized gingiva (time frame: after 1 month and 3 months). The study lists 2 primary outcomes in all. 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 NCT06065254, which also lists 5 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 3 Oct 2023.