Peri-implant MucositisNCT04042194
Comparison of CTG and T-PRF on Peri-Implant Soft Tissue
A study testing Placement of Implants and Thickening Peri-Implant Mucosa with T-PRF and Placement of Implants and Thickening Peri-Implant Mucosa with CTG in people with Peri-implant Mucositis and Peri-Implantitis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The present study aimed to increase the thickness of the gingiva and prevent possible crestal bone resorption by placing the CTG or T-PRF membrane under the mucosa immediately after the implant treatment in individuals with thin gingival phenotype. Read more about this study
- Who is it for?
- Ages 29 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis, Peri-Implantitis, Thin Gingiva
- What is being tested?
- Placement of Implants and Thickening Peri-Implant Mucosa with T-PRF and Placement of Implants and Thickening Peri-Implant Mucosa with CTG
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 1 Jul 2019
- 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 29 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients older than 18 years,
- thin gingiva biotype,
- one missing tooth in the incisor, canine and premolar area and presence of two natural adjacent teeth
- no bone increasing procedures prior to and during dental implant,
Who cannot join
- history of a bleeding disorder or on anticoagulant therapy,
- immunocompromised state and debilitating disease,
- smoking and alcoholism,
- poor oral hygiene,
- diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Connective Tissue Graft (CTG) and Titanium Prepared Platelet-Rich Fibrin (T-PRF) Inserted With a Double Layer Technique on Peri-Implant Soft Tissue Thickening: A Randomized Prospective Clinical Study
The present study aimed to increase the thickness of the gingiva and prevent possible crestal bone resorption by placing the CTG or T-PRF membrane under the mucosa immediately after the implant treatment in individuals with thin gingival phenotype. The null hypothesis was that T-PRF used simultaneously with implant placement can be considered an alternative to CTG.
Read the detailed description
Although connective tissue graft (CTG) is considered as the best technique for soft tissue augmentation, limited supply of donor tissue because of palatal vessels and nerves, and postoperative pain may require alternative methods.
The purpose of this study is to reduce the crestal bone resorption around the implant site by augmenting the Peri-Implant Soft Tissue with T-PRF (titanium prepared platelet-rich fibrin) or CTG and to compare the effectiveness of the two techniques.
Through simultaneous augmentation of the soft tissue by T-PRF or CTG, a total of 30 implants were implanted in 30 patients (12 males, 18 females) with a mean age of 38.4 years. In the test group, implants were placed in thin tissues and thickened with T- PRF membrane at the same time, while in the control group, implants were placed in thin tissues and thickened with CTG at the same time. During the surgery (T 0 ) and at postoperative 3 months (T 1 ), keratinised tissue width (KTW) and Peri-Implant soft tissue thickness (STT) were measured from three points: occlusal part of the alveolar crest (OAC), midbuccal mucosa level (MBML), and over 1 mm of mucogingival junction (MGJ1).
- Conditions
- Peri-implant Mucositis, Peri-Implantitis, Thin Gingiva
- Being tested
- Placement of Implants and Thickening Peri-Implant Mucosa with T-PRF, Placement of Implants and Thickening Peri-Implant Mucosa with CTG
- Keywords
- clinical research, Implant, Implantology, Prospective, Randomized controlled trial, Soft Tissue Grafting, Single-Tooth Implants
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of Implants and Thickening Peri-Implant Mucosa with T-PRFProcedure or surgery
A total of 40 ml blood sample was collected from the antecubital vein of the patients' right or left arms with 10 ml injectors. 40 ml blood was transferred to a grade-IV titanium tube for the T-PRF group. The titanium tubes containing the blood samples were instantly centrifuged in a tabletop centrifuge at room temperature. The blood samples of the T-PRF group were centrifuged clockwise at 2700 RPM for 20 minutes. Subsequent to the centrifugation process, the clots of the T-PRF group were removed from the tubes with sterile tweezers, separated from the RBC base with scissors, and left for over 20 minutes on sterile woven gauze to release the serum slowly from the collected clots. The implants were placed in thin tissues, and the thickness of the thin tissues was simultaneously increased with T-PRF.
Placement of Implants and Thickening Peri-Implant Mucosa with CTGProcedure or surgery
The implants were placed in thin tissues, and the thickness of the thin tissues was simultaneously increased with CTG. Autogenous connective tissue graft was harvested according to a single incision technique.
| Study group | Role | What they receive |
|---|---|---|
| Thickened with T-PRF | Experimental | Following local anaesthesia, the measurement of soft tissue thickness at three points [1) occlusal part of the alveolar crest (OAC), 2) midbuccal mucosa level (MBML), 3) over 1 mm of mucogingival junction (MGJ1)] was performed with an endodontic spreader and digital caliber. Following the mid-crestal incision, the buccal flap was raised with double layer technique, while the lingual flap was left to enable direct visibility. The implant bed was drilled according to the manufacturer's protocol. The implants (BEGO Semados® RS/RSX implant system, Bremen, Germany) were placed at the bony crest. Right after the implant placement, the randomisation procedure was performed. In this group, the implants were placed in thin tissues, and T-PRF was inserted in the prepared mucoperiosteal flap at the facial site and secured with horizontal mattresses. Receives: Procedure: Placement of Implants and Thickening Peri-Implant Mucosa with T-PRF |
| Thickened with CTG | Active comparator | Following local anaesthesia, the measurement of soft tissue thickness at three points [1) occlusal part of the alveolar crest (OAC), 2) midbuccal mucosa level (MBML), 3) over 1 mm of mucogingival junction (MGJ1)] was performed with an endodontic spreader and digital caliber. Following the mid-crestal incision, the buccal flap was raised with double layer technique, while the lingual flap was left to enable direct visibility. The implant bed was drilled according to the manufacturer's protocol. The implants (BEGO Semados® RS/RSX implant system, Bremen, Germany) were placed at the bony crest. Right after the implant placement, the randomisation procedure was performed. In this group, the implants were placed in thin tissues, and CTG was inserted in the prepared mucoperiosteal flap at the facial site and secured with horizontal mattresses. Receives: Procedure: Placement of Implants and Thickening Peri-Implant Mucosa with CTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant Soft Tissue Thickness
The measurement of soft tissue thickness at three points: occlusal part of the alveolar crest (OAC), midbuccal mucosa level (MBML), over 1 mm of mucogingival junction (MGJ1)]
Measured: Change from baseline soft tissue thickness at 3 months
Secondary outcomes (1)
Keratinised Tissue Width (KTW)
The measurement of the keratinised tissue width between the cover screw and the mucogingival junction.
Measured: Change from baseline keratinised tissue width at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Jul 2018
- Primary completion1 Apr 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulbahar, Abant Izzet Baysal University
- Investigators
- Gülbahar Ustaoğlu, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042194
- Sponsor's protocol ID
- 2018/68
- Status last verified
- Jul 2019
- First submitted
- 30 Jul 2019
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Connective Tissue Graft (CTG) and Titanium Prepared Platelet-Rich Fibrin (T-PRF) Inserted With a Double Layer Technique on Peri-Implant Soft Tissue Thickening: A Randomized Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04042194
- Acronym / sponsor ID
- 2018/68
- Conditions
- Peri-implant Mucositis, Peri-Implantitis, Thin Gingiva
- Keywords
- clinical research, Implant, Implantology, Prospective, Randomized controlled trial, Soft Tissue Grafting, Single-Tooth Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 1 Aug 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.
The present study aimed to increase the thickness of the gingiva and prevent possible crestal bone resorption by placing the CTG or T-PRF membrane under the mucosa immediately after the implant treatment in individuals with thin gingival phenotype. The null hypothesis was that T-PRF used simultaneously with implant placement can be considered an alternative to CTG.
Detailed description
Although connective tissue graft (CTG) is considered as the best technique for soft tissue augmentation, limited supply of donor tissue because of palatal vessels and nerves, and postoperative pain may require alternative methods.
The purpose of this study is to reduce the crestal bone resorption around the implant site by augmenting the Peri-Implant Soft Tissue with T-PRF (titanium prepared platelet-rich fibrin) or CTG and to compare the effectiveness of the two techniques.
Through simultaneous augmentation of the soft tissue by T-PRF or CTG, a total of 30 implants were implanted in 30 patients (12 males, 18 females) with a mean age of 38.4 years. In the test group, implants were placed in thin tissues and thickened with T- PRF membrane at the same time, while in the control group, implants were placed in thin tissues and thickened with CTG at the same time. During the surgery (T 0 ) and at postoperative 3 months (T 1 ), keratinised tissue width (KTW) and Peri-Implant soft tissue thickness (STT) were measured from three points: occlusal part of the alveolar crest (OAC), midbuccal mucosa level (MBML), and over 1 mm of mucogingival junction (MGJ1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thickened with T-PRF | Experimental | Procedure: Placement of Implants and Thickening Peri-Implant Mucosa with T-PRFFollowing local anaesthesia, the measurement of soft tissue thickness at three points [1) occlusal part of the alveolar crest (OAC), 2) midbuccal mucosa level (MBML), 3) over 1 mm of mucogingival junction (MGJ1)] was performed with an endodontic spreader and digital caliber. Following the mid-crestal incision, the buccal flap was raised with double layer technique, while the lingual flap was left to enable direct visibility. The implant bed was drilled according to the manufacturer's protocol. The implants (BEGO Semados® RS/RSX implant system, Bremen, Germany) were placed at the bony crest. Right after the implant placement, the randomisation procedure was performed. In this group, the implants were placed in thin tissues, and T-PRF was inserted in the prepared mucoperiosteal flap at the facial site and secured with horizontal mattresses. |
| Thickened with CTG | Active comparator | Procedure: Placement of Implants and Thickening Peri-Implant Mucosa with CTGFollowing local anaesthesia, the measurement of soft tissue thickness at three points [1) occlusal part of the alveolar crest (OAC), 2) midbuccal mucosa level (MBML), 3) over 1 mm of mucogingival junction (MGJ1)] was performed with an endodontic spreader and digital caliber. Following the mid-crestal incision, the buccal flap was raised with double layer technique, while the lingual flap was left to enable direct visibility. The implant bed was drilled according to the manufacturer's protocol. The implants (BEGO Semados® RS/RSX implant system, Bremen, Germany) were placed at the bony crest. Right after the implant placement, the randomisation procedure was performed. In this group, the implants were placed in thin tissues, and CTG was inserted in the prepared mucoperiosteal flap at the facial site and secured with horizontal mattresses. |
Who may qualify
- Ages
- 29 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients older than 18 years,
- thin gingiva biotype,
- one missing tooth in the incisor, canine and premolar area and presence of two natural adjacent teeth
- no bone increasing procedures prior to and during dental implant,
Key exclusion criteria (5 listed)
- history of a bleeding disorder or on anticoagulant therapy,
- immunocompromised state and debilitating disease,
- smoking and alcoholism,
- poor oral hygiene,
- diabetes.
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 |
|---|---|---|
| Placement of Implants and Thickening Peri-Implant Mucosa with T-PRFA total of 40 ml blood sample was collected from the antecubital vein of the patients' right or left arms with 10 ml injectors. 40 ml blood was transferred to a grade-IV titanium tube for the T-PRF group. The titanium tubes containing the blood samples were instantly centrifuged in a tabletop centrifuge at room temperature. The blood samples of the T-PRF group were centrifuged clockwise at 2700 RPM for 20 minutes. Subsequent to the centrifugation process, the clots of the T-PRF group were removed from the tubes with sterile tweezers, separated from the RBC base with scissors, and left for over 20 minutes on sterile woven gauze to release the serum slowly from the collected clots. The implants were placed in thin tissues, and the thickness of the thin tissues was simultaneously increased with T-PRF. | Procedure or surgery | Thickened with T-PRF |
| Placement of Implants and Thickening Peri-Implant Mucosa with CTGThe implants were placed in thin tissues, and the thickness of the thin tissues was simultaneously increased with CTG. Autogenous connective tissue graft was harvested according to a single incision technique. | Procedure or surgery | Thickened with CTG |
Primary outcome
Peri-implant Soft Tissue Thickness
Time frame: Change from baseline soft tissue thickness at 3 months
The measurement of soft tissue thickness at three points: occlusal part of the alveolar crest (OAC), midbuccal mucosa level (MBML), over 1 mm of mucogingival junction (MGJ1)]
1 secondary outcome
Keratinised Tissue Width (KTW)
Time frame: Change from baseline keratinised tissue width at 3 months
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 1 Aug 2019.
- 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.
Gülbahar Ustaoğlu principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of Implants and Thickening Peri-Implant Mucosa with T-PRF and Placement of Implants and Thickening Peri-Implant Mucosa with CTG in people with Peri-implant Mucositis and Peri-Implantitis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 5 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 1 Aug 2019. 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 Turkey (Türkiye). 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?
Peri-implant Soft Tissue Thickness (time frame: Change from baseline soft tissue thickness at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2019.