Keratinized MucosaFGGSNCT06694623
Keratinized Tissue Gain Following Apically Positioned Flap with and Without Free Gingival Graft Strip
A study testing Apically positioned flap and Apically positioned flap with FGG strip in people with Keratinized Mucosa, run by Adam Malesevic at 1 site in Serbia.
Trial summary
In non-implant edentulous patients reduction of height and width of residual alveolar ridge and reduced attached KT compromise the denture-bearing area unambiguously leading to decrease in full denture stability and retention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratinized Mucosa
- What is being tested?
- Apically positioned flap and Apically positioned flap with FGG strip
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Mar 2023to 10 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with edentulous upper jaws which are not able to wear full upper denture owing to compromise retention and stability being 18 years old or older,
- patients with reduced width of keratinized tissue (≤ 4mm) measured from middle of the crest to the buccal mucogingival junction ( the distance from occluso-buccal edge of the alveolar ridge to the mucogingival junction ≤ 2mm), - patients who belong to ASA1 or ASA2, according to the American Academy to Anesthesiology
- patients who do not suffer from any systemic disease affecting wound healing,
- patients which are able to provide a signed informed consent and are able to comply with determined follow-up time points.
Who cannot join
- patient is a heavy smoker (more than 10 cigarettes per day),
- patients with history of malignancy, radiotherapy or chemotherapy within the 5 years,
- pregnant or nursing patients,
- patients who are taking medications which have an effect on mucosal healing in general (steroids, non-steroidal anti-inflammatory drugs taken in high doses and in long term, bisphosphonates).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Keratinized Tissue Regeneration Following Apically Positioned Flap with and Without Free Gingival Graft Strip: a Split Mouth Randomized Clinical Trial
In non-implant edentulous patients reduction of height and width of residual alveolar ridge and reduced attached KT compromise the denture-bearing area unambiguously leading to decrease in full denture stability and retention. Furthermore, in implant edentulous patients insufficient KT is associated with increased plaque accumulation, tissue inflammation, soft tissue recession, marginal bone loss and increased prevalence of peri-implantitis. The present study aimed to evaluate keratinized tissue gain and the wound contraction rate between apically positioned flap without and with free gingival graft strip over a 6-month follow up period.
This research was designed as split mouth controlled clinical study included 17 patients having edentulous upper jaw with reduced width of keratinized tissue ( ≤ 4mm measured from middle of the crest to the buccal mucogingival junction or ≤ 2mm from occluso-buccal edge of the alveolar ridge to the mucogingival junction). In each patient, both surgical techniques, apically positioned flap without and with free gingival graft strip, were applied simultaneously. The change of keratinized tissue width and wound contraction rate were measured 30, 60 , 90 and 180 days after surgery
Read the detailed description
The surgical procedure was done by one experienced surgeon. Before surgery, patients were given to rinse the mouth with 0,12% clorhexidine gluconate for 1 minute. Following the local anesthesia utilizing Artikaine 4% with 1:100000 epinephrine the elevation of split-thickness flap was started. Incision was done at the level of MGJ from maxillary tuberosity on one side to tuberosity of the opposite side. Initially, sharp dissection was carefully done in an apical direction to leave exposed periosteum without tearing. Further, blunt dissection was used to advance periosteum exposure and muscle fibres detachment. For apically positioned flap group the split thickness flap was apically positioned as much as possible and sutured to the periosteum utilizing T-mattress sutures. Regarding free gingival graft strip group, after the split thickness flap was sutured apically, free gingival graft in the form of strip, harvested from the palate, was sutured to the apical end of the recipient bed leaving the rest of periosteum to heal by secondary epitelization. Free gingival graft strip stabilized with 6-0 resorbable sutures by means of two single interrupted and cross-mattress sutures. The dimensions of free gingival graft strip was 30-35mm in length (depending on the length of the apical part of recipient bed), 2-3mm in width and 1-1.5mm in thick. The palatal donor site was sutured using cross-mattress sutures. Patients were given postoperative instructions which included antibiotics regime (amoxicillin 500mg, 3x1 for 5 days or in case of penicillin allergy- clindamycin 600mg, 2x1 5 days) and rinsing with chlorehexidine solution 0.12% two times a day for 14 days.
To control for bias, measurements were carried out by one examiner not involved in the surgical procedure. Measurements were taken from regions representing tooth #16 to tooth #26. The colour-coded periodontal probe (University of North Caroline Probe CP15 PCPUNC156, Hy Friedy) utilized to measure the distance from depth of newly formed vestibule to the edge of vertical cut made on the GM representing position of certain tooth. Measurement for each tooth were summarized in three regions: anterior group (central and lateral incisor region)- AG, middle group (canine, first and second premolar region)- MG and posterior group (first molar region)- PG.
First measurement was done immediately after surgery (T0) and represented the distance from depth of newly formed vestibule to the edge of vertical cut made on the GM (for apically positioned flap group) and from apical margin of free gingival graft strip to the edge of vertical cut made on the GM (for free gingival graft strip group). Follow up measurements were taken at 30 (T1), 60 (T2) , 90 (T3) and 180 (T4) days after surgery.
Primary outcome was wound contraction rate representing the percentage of keratinized tissue reduction between time point immediately after surgery (T0, 100%) and follow-up time points (T1,T2,T3 and T4). Secondary outcomes were 1) patient-reported outcomes such as patient discomfort and pain which was evaluated utilizing visual analogue scale (VAS) at 1, 2, 7 and 10 days after surgery and the amount of ibuprofen taking within 10 days after surgery, 2) the surgery time which represented the time from first incision to the last suture with a digital timer rounded to the whole minutes, 3) wound infection (yes/no), and wound bleeding (yes/no).
- Conditions
- Keratinized Mucosa
- Being tested
- Apically positioned flap, Apically positioned flap with FGG strip
- Keywords
- keratinized mucosa, free gingival graft strip, apically positioned flap, wound contraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apically positioned flapProcedure or surgery
The split thickness flap was apically positioned as much as possible and sutured to the periosteum utilizing T-mattress sutures.
Apically positioned flap with FGG stripProcedure or surgery
The split thickness flap was apically positioned as much as possible and sutured to the periosteum utilizing T-mattress sutures. FGG strip was sutured to the apical end of recipient bed.
| Study group | Role | What they receive |
|---|---|---|
| apically positioned flap alone | Active comparator | apically positioned flap alone Receives: Procedure: Apically positioned flap |
| apically positioned flap with FGG strip | Active comparator | apically positioned flap with FGG strip Receives: Procedure: Apically positioned flap with FGG strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound contraction rate
Percentage of tissue tissue contraction during healing period
Measured: From enrollment to the 180 day
Secondary outcomes (3)
Pain
Visual Analogue Scale (VAS) 100mm long will be used. The greater the value the greater the pain. The left end of scale is 0mm (no pain), and the right end of scale iz 100mm (the greatest pain that patient can imagine).
Measured: 1, 2, 7 and 10 day postoperatively
number of ibuprofen tablets
Measured: 1, 2, 7, 10 days postoperatively
Surgery duration
Duration of surgery will be recorded in minutes.
Measured: From start to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Mar 2023
- Primary completion15 Dec 2023
- Study completion10 Oct 2024
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 Keratinized MucosaStudies 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
- Factorial
- Model description
- Split mouth
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adam Malesevic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Belgrade
- Responsible party
- Sponsor-investigator, Adam Malesevic, University of Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694623
- Sponsor's protocol ID
- 106/2-2023
- Other IDs
- Faculty of Dentistry Pancevo
- Acronym
- FGGS
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Urban IA, Lozada JL, Nagy K, Sanz M. Treatment of severe mucogingival defects with a combination of strip gingival grafts and a xenogeneic collagen matrix: a prospective case series study. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):345-53. doi: 10.11607/prd.2287.
PubMed 25909521Arnoux JP, Papasotiriou A, Weisgold AS. A revised technique for stage-two surgery in the severely resorbed mandible: a technical note. Int J Oral Maxillofac Implants. 1998 Jul-Aug;13(4):565-8.
PubMed 9714965Gamal N, Shemais N, Al-Nawawy M, Ghallab NA. Post-extraction volumetric analysis of alveolar ridge contour using subepithelial connective tissue graft in esthetic zone: a randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6503-6512. doi: 10.1007/s00784-023-05255-0. Epub 2023 Sep 19.
PubMed 37726486Song YW, Yoon SW, Cha JK, Jung UW, Jung RE, Thoma DS. Soft Tissue Dimensions Following Tooth Extraction in the Posterior Maxilla: A Randomized Clinical Trial Comparing Alveolar Ridge Preservation to Spontaneous Healing. J Clin Med. 2020 Aug 10;9(8):2583. doi: 10.3390/jcm9082583.
PubMed 32784997De Angelis P, De Rosa G, Manicone PF, De Giorgi A, Cavalcanti C, Speranza A, Grassi R, D'Addona A. Hard and soft tissue evaluation of alveolar ridge preservation compared to spontaneous healing: a retrospective clinical and volumetric analysis. Int J Implant Dent. 2022 Dec 8;8(1):62. doi: 10.1186/s40729-022-00456-w.
PubMed 36480055Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
PubMed 12956475
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keratinized Tissue Regeneration Following Apically Positioned Flap with and Without Free Gingival Graft Strip: a Split Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06694623
- Acronym / sponsor ID
- FGGS / 106/2-2023
- Conditions
- Keratinized Mucosa
- Keywords
- keratinized mucosa, free gingival graft strip, apically positioned flap, wound contraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Adam MalesevicUniversity, hospital or other
- Collaborators
- University of Belgrade
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 19 Nov 2024 (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 non-implant edentulous patients reduction of height and width of residual alveolar ridge and reduced attached KT compromise the denture-bearing area unambiguously leading to decrease in full denture stability and retention. Furthermore, in implant edentulous patients insufficient KT is associated with increased plaque accumulation, tissue inflammation, soft tissue recession, marginal bone loss and increased prevalence of peri-implantitis. The present study aimed to evaluate keratinized tissue gain and the wound contraction rate between apically positioned flap without and with free gingival graft strip over a 6-month follow up period.
This research was designed as split mouth controlled clinical study included 17 patients having edentulous upper jaw with reduced width of keratinized tissue ( ≤ 4mm measured from middle of the crest to the buccal mucogingival junction or ≤ 2mm from occluso-buccal edge of the alveolar ridge to the mucogingival junction). In each patient, both surgical techniques, apically positioned flap without and with free gingival graft strip, were applied simultaneously. The change of keratinized tissue width and wound contraction rate were measured 30, 60 , 90 and 180 days after surgery
Detailed description
The surgical procedure was done by one experienced surgeon. Before surgery, patients were given to rinse the mouth with 0,12% clorhexidine gluconate for 1 minute. Following the local anesthesia utilizing Artikaine 4% with 1:100000 epinephrine the elevation of split-thickness flap was started. Incision was done at the level of MGJ from maxillary tuberosity on one side to tuberosity of the opposite side. Initially, sharp dissection was carefully done in an apical direction to leave exposed periosteum without tearing. Further, blunt dissection was used to advance periosteum exposure and muscle fibres detachment. For apically positioned flap group the split thickness flap was apically positioned as much as possible and sutured to the periosteum utilizing T-mattress sutures. Regarding free gingival graft strip group, after the split thickness flap was sutured apically, free gingival graft in the form of strip, harvested from the palate, was sutured to the apical end of the recipient bed leaving the rest of periosteum to heal by secondary epitelization. Free gingival graft strip stabilized with 6-0 resorbable sutures by means of two single interrupted and cross-mattress sutures. The dimensions of free gingival graft strip was 30-35mm in length (depending on the length of the apical part of recipient bed), 2-3mm in width and 1-1.5mm in thick. The palatal donor site was sutured using cross-mattress sutures. Patients were given postoperative instructions which included antibiotics regime (amoxicillin 500mg, 3x1 for 5 days or in case of penicillin allergy- clindamycin 600mg, 2x1 5 days) and rinsing with chlorehexidine solution 0.12% two times a day for 14 days.
To control for bias, measurements were carried out by one examiner not involved in the surgical procedure. Measurements were taken from regions representing tooth #16 to tooth #26. The colour-coded periodontal probe (University of North Caroline Probe CP15 PCPUNC156, Hy Friedy) utilized to measure the distance from depth of newly formed vestibule to the edge of vertical cut made on the GM representing position of certain tooth. Measurement for each tooth were summarized in three regions: anterior group (central and lateral incisor region)- AG, middle group (canine, first and second premolar region)- MG and posterior group (first molar region)- PG.
First measurement was done immediately after surgery (T0) and represented the distance from depth of newly formed vestibule to the edge of vertical cut made on the GM (for apically positioned flap group) and from apical margin of free gingival graft strip to the edge of vertical cut made on the GM (for free gingival graft strip group). Follow up measurements were taken at 30 (T1), 60 (T2) , 90 (T3) and 180 (T4) days after surgery.
Primary outcome was wound contraction rate representing the percentage of keratinized tissue reduction between time point immediately after surgery (T0, 100%) and follow-up time points (T1,T2,T3 and T4). Secondary outcomes were 1) patient-reported outcomes such as patient discomfort and pain which was evaluated utilizing visual analogue scale (VAS) at 1, 2, 7 and 10 days after surgery and the amount of ibuprofen taking within 10 days after surgery, 2) the surgery time which represented the time from first incision to the last suture with a digital timer rounded to the whole minutes, 3) wound infection (yes/no), and wound bleeding (yes/no).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split mouth
| Arm | Type | Receives |
|---|---|---|
| apically positioned flap alone | Active comparator | Procedure: Apically positioned flapapically positioned flap alone |
| apically positioned flap with FGG strip | Active comparator | Procedure: Apically positioned flap with FGG stripapically positioned flap with FGG strip |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with edentulous upper jaws which are not able to wear full upper denture owing to compromise retention and stability being 18 years old or older,
- patients with reduced width of keratinized tissue (≤ 4mm) measured from middle of the crest to the buccal mucogingival junction ( the distance from occluso-buccal edge of the alveolar ridge to the mucogingival junction ≤ 2mm), - patients who belong to ASA1 or ASA2, according to the American Academy to Anesthesiology
- patients who do not suffer from any systemic disease affecting wound healing,
- patients which are able to provide a signed informed consent and are able to comply with determined follow-up time points.
Key exclusion criteria (4 listed)
- patient is a heavy smoker (more than 10 cigarettes per day),
- patients with history of malignancy, radiotherapy or chemotherapy within the 5 years,
- pregnant or nursing patients,
- patients who are taking medications which have an effect on mucosal healing in general (steroids, non-steroidal anti-inflammatory drugs taken in high doses and in long term, bisphosphonates).
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 |
|---|---|---|
| Apically positioned flapThe split thickness flap was apically positioned as much as possible and sutured to the periosteum utilizing T-mattress sutures. | Procedure or surgery | apically positioned flap alone |
| Apically positioned flap with FGG stripThe split thickness flap was apically positioned as much as possible and sutured to the periosteum utilizing T-mattress sutures. FGG strip was sutured to the apical end of recipient bed. | Procedure or surgery | apically positioned flap with FGG strip |
Primary outcome
Wound contraction rate
Time frame: From enrollment to the 180 day
Percentage of tissue tissue contraction during healing period
3 secondary outcomes
Pain
Time frame: 1, 2, 7 and 10 day postoperatively
number of ibuprofen tablets
Time frame: 1, 2, 7, 10 days postoperatively
Surgery duration
Time frame: From start to the end of surgery
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 19 Nov 2024.
- Background: PubMed 25909521Urban IA, Lozada JL, Nagy K, Sanz M. Treatment of severe mucogingival defects with a combination of strip gingival grafts and a xenogeneic collagen matrix: a prospective case series study. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):345-53. doi: 10.11607/prd.2287.
- Background: PubMed 9714965Arnoux JP, Papasotiriou A, Weisgold AS. A revised technique for stage-two surgery in the severely resorbed mandible: a technical note. Int J Oral Maxillofac Implants. 1998 Jul-Aug;13(4):565-8.
- Background: PubMed 37726486Gamal N, Shemais N, Al-Nawawy M, Ghallab NA. Post-extraction volumetric analysis of alveolar ridge contour using subepithelial connective tissue graft in esthetic zone: a randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6503-6512. doi: 10.1007/s00784-023-05255-0. Epub 2023 Sep 19.
- Background: PubMed 32784997Song YW, Yoon SW, Cha JK, Jung UW, Jung RE, Thoma DS. Soft Tissue Dimensions Following Tooth Extraction in the Posterior Maxilla: A Randomized Clinical Trial Comparing Alveolar Ridge Preservation to Spontaneous Healing. J Clin Med. 2020 Aug 10;9(8):2583. doi: 10.3390/jcm9082583.
- Background: PubMed 36480055De Angelis P, De Rosa G, Manicone PF, De Giorgi A, Cavalcanti C, Speranza A, Grassi R, D'Addona A. Hard and soft tissue evaluation of alveolar ridge preservation compared to spontaneous healing: a retrospective clinical and volumetric analysis. Int J Implant Dent. 2022 Dec 8;8(1):62. doi: 10.1186/s40729-022-00456-w.
- Background: PubMed 12956475Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
- 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.
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 Apically positioned flap and Apically positioned flap with FGG strip in people with Keratinized Mucosa, run by Adam Malesevic at 1 site in Serbia.
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 4 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 19 Nov 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 Serbia. 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?
Wound contraction rate (time frame: From enrollment to the 180 day). 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 NCT06694623, 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 19 Nov 2024.