Papilla, Dentinal; CalcificationCGFNCT03635931
Surgical Treatment With Concentrated Growth Factor for Multiple Papillary Losses
A study testing Concentrated Growth Factor in people with Papilla, Dentinal; Calcification, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the efficacy of concentrated growth factor (CGF) in applied in the regenerative treatment of multiple adjacent papillary black triangles (MAPBT) occured as a result of soft tissue loss. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Papilla, Dentinal; Calcification
- What is being tested?
- Concentrated Growth Factor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2017to 12 Aug 2018
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of interdental papillary losses in the maxillary anterior teeth, between the adjacent central teeth, the central and lateral teeth and the lateral and canine teeth
- The presence of a contact point in the maxillary anterior teeth
- optimal facial keratinized gingiva/ keratinized gingiva must be more than 2mm
Who cannot join
- pregnancy or
- breast-feeding,
- palatal and gingival recession,
- attachment loss,
- high labial frenulum.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Dentistry Department of Periodontology
Ankara, Çankaya, 06510
About this study
Official title: Efficiency of Concentrated Growth Factor in the Surgical Treatment of Multiple Adjacent Papillary Losses: a Controlled, Examiner-blinded Clinical Study
The aim of this study was to evaluate the efficacy of concentrated growth factor (CGF) in applied in the regenerative treatment of multiple adjacent papillary black triangles (MAPBT) occured as a result of soft tissue loss. Interdental papillary regeneration was evaluated with the change in the area of interproximal spaces calculated on each of the intraorally scanned images obtained with digital impressions of the interproximal space with irregular borders.This controlled, examiner-blinded, clinical study included of 40 patients with 120 open embrasures which resulted from papillary loss in adjacent teeth in the anterior maxillary esthetic zone resulting in black triangles (BTs). Then patients were randomly assigned to receive surgical regenerative periodontal treatment(test) or periodontal care(control)The test group was formed of 20 patients with 60 adjacent papillary defects . A control group was formed of 20 patients with 60 adjacent papillary defects.. A total of 480 images obtained with the digital impressions . Evaluations of the test group were made preoperatively and at 3, 6 and 12 months postoperatively. For the control group, oral hygiene instruction was provided. Control group is evaluated by the same procedure with test group but the surgical part is not performed. Lost interdental papillary area (PA)were calculated. In the test group, the percentage of papillary filling, the presence of keratinized gingiva, the thickness of papillary gingiva, blood thrombocyte count and mean platelet volume values(MPV) were recorded.
Read the detailed description
The treatment of open gingival embrasures, which are also known as black triangles (BT) or black holes, and cause esthetic, functional and phonetic problems in the anterior region, has become an area of interest in current periodontal treatment.Surgical, non-surgical and prosthetic methods are applied in the treatment of BT, which can be seen in more than half of adults. This study aimed to evaluate the efficacy of concentrated growth factor (CGF) in regenerating interdental papillary of multiple adjacent papillary black triangles (MAPBT) occured as a result of soft tissue loss. Interdental papillary regeneration was evaluated with the change in the area of interproximal spaces calculated on each of the intraorally scanned images obtained with digital impressions of the interproximal space with irregular borders.
This controlled, examiner-blinded, randomized clinical study included 160 teeth of 40 patients with 120 open embrasures which resulted from papillary loss in adjacent teeth in the anterior maxillary esthetic zone resulting in black triangles (BTs). The test group was formed of 20 patients with 60 adjacent papillary defects undergoing minimally invasive surgery for papillary regeneration with CGF. A control group was formed of 20 patients with 60 adjacent papillary defects who were not included surgical treatment. A total of 480 images obtained with the digital impressions method of each interdental papillary region in each patient were uploaded to a special software. Evaluations of the test group were made preoperatively and at 3, 6 and 12 months postoperatively. For the control group, oral hygiene instruction was provided. Control group is evaluated by the same procedure with test group but the surgical part is not performed. Lost interdental papillary area (PA)were calculated between the two central teeth, between the lateral and central teeth, and between the lateral and canine teeth prior to the treatment and at pro-treatment periods of 3, 6 and 12 months in both of the groups. In the test group, the percentage of papillary filling, the presence of keratinized gingiva, the thickness of papillary gingiva, blood thrombocyte count and MPV values were recorded.
- Conditions
- Papilla, Dentinal; Calcification
- Being tested
- Concentrated Growth Factor
- Keywords
- CGF, lost interdental papilla
- Medical subject headings
- Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated Growth FactorProcedure or surgery
surgical treatment with CGF for papilla regeneration
| Study group | Role | What they receive |
|---|---|---|
| Concentrated Growth Factor | Active comparator | plaque control, scaling and root planing if required, surgical application of CGF Receives: Procedure: Concentrated Growth Factor |
| Control Group | No intervention | plaque control, scaling and root planing if required |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the percentage of papillary fill(PF)
The percentage of PF was also calculated as ([ Lost Papillary area(PA) preoperation - PA postoperation] / PA preoperation) x 100%.
Measured: Change from 3 months percentage of papillary fill at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start30 Jul 2017
- Primary completion30 Jul 2018
- Study completion12 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papilla, Dentinal; CalcificationStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Model description
- The test and control group was formed of patients with adjacent papillary defects In test group, elective minimally invasive surgery for papillary regeneration with CGF was performed. A control group was formed of patients with adjacent papillary defects who were not included to have surgical treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University
- Responsible party
- Principal investigator, Zeynep Turgut Çankaya, Gazi University
- Investigators
- zeynep Turgut Çankaya, PhD,Dr, Principal investigator, Gazi University, Faculty of Dentistry,Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635931
- Sponsor's protocol ID
- 36290600
- Acronym
- CGF
- Status last verified
- Jul 2019
- First submitted
- 13 Aug 2018
- Last updated
- 30 Jul 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 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Concentrated Growth Factor in the Surgical Treatment of Multiple Adjacent Papillary Losses: a Controlled, Examiner-blinded Clinical Study
- ClinicalTrials.gov ID
- NCT03635931
- Acronym / sponsor ID
- CGF / 36290600
- Conditions
- Papilla, Dentinal; Calcification
- Keywords
- CGF, lost interdental papilla
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Ankara University
- Study start
- 30 Jul 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 12 Aug 2018 (actual)
- First posted
- 17 Aug 2018 (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 aim of this study was to evaluate the efficacy of concentrated growth factor (CGF) in applied in the regenerative treatment of multiple adjacent papillary black triangles (MAPBT) occured as a result of soft tissue loss. Interdental papillary regeneration was evaluated with the change in the area of interproximal spaces calculated on each of the intraorally scanned images obtained with digital impressions of the interproximal space with irregular borders.This controlled, examiner-blinded, clinical study included of 40 patients with 120 open embrasures which resulted from papillary loss in adjacent teeth in the anterior maxillary esthetic zone resulting in black triangles (BTs). Then patients were randomly assigned to receive surgical regenerative periodontal treatment(test) or periodontal care(control)The test group was formed of 20 patients with 60 adjacent papillary defects . A control group was formed of 20 patients with 60 adjacent papillary defects.. A total of 480 images obtained with the digital impressions . Evaluations of the test group were made preoperatively and at 3, 6 and 12 months postoperatively. For the control group, oral hygiene instruction was provided. Control group is evaluated by the same procedure with test group but the surgical part is not performed. Lost interdental papillary area (PA)were calculated. In the test group, the percentage of papillary filling, the presence of keratinized gingiva, the thickness of papillary gingiva, blood thrombocyte count and mean platelet volume values(MPV) were recorded.
Detailed description
The treatment of open gingival embrasures, which are also known as black triangles (BT) or black holes, and cause esthetic, functional and phonetic problems in the anterior region, has become an area of interest in current periodontal treatment.Surgical, non-surgical and prosthetic methods are applied in the treatment of BT, which can be seen in more than half of adults. This study aimed to evaluate the efficacy of concentrated growth factor (CGF) in regenerating interdental papillary of multiple adjacent papillary black triangles (MAPBT) occured as a result of soft tissue loss. Interdental papillary regeneration was evaluated with the change in the area of interproximal spaces calculated on each of the intraorally scanned images obtained with digital impressions of the interproximal space with irregular borders.
This controlled, examiner-blinded, randomized clinical study included 160 teeth of 40 patients with 120 open embrasures which resulted from papillary loss in adjacent teeth in the anterior maxillary esthetic zone resulting in black triangles (BTs). The test group was formed of 20 patients with 60 adjacent papillary defects undergoing minimally invasive surgery for papillary regeneration with CGF. A control group was formed of 20 patients with 60 adjacent papillary defects who were not included surgical treatment. A total of 480 images obtained with the digital impressions method of each interdental papillary region in each patient were uploaded to a special software. Evaluations of the test group were made preoperatively and at 3, 6 and 12 months postoperatively. For the control group, oral hygiene instruction was provided. Control group is evaluated by the same procedure with test group but the surgical part is not performed. Lost interdental papillary area (PA)were calculated between the two central teeth, between the lateral and central teeth, and between the lateral and canine teeth prior to the treatment and at pro-treatment periods of 3, 6 and 12 months in both of the groups. In the test group, the percentage of papillary filling, the presence of keratinized gingiva, the thickness of papillary gingiva, blood thrombocyte count and MPV values were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The test and control group was formed of patients with adjacent papillary defects In test group, elective minimally invasive surgery for papillary regeneration with CGF was performed. A control group was formed of patients with adjacent papillary defects who were not included to have surgical treatment.
| Arm | Type | Receives |
|---|---|---|
| Concentrated Growth Factor | Active comparator | Procedure: Concentrated Growth Factorplaque control, scaling and root planing if required, surgical application of CGF |
| Control Group | No intervention | –plaque control, scaling and root planing if required |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of interdental papillary losses in the maxillary anterior teeth, between the adjacent central teeth, the central and lateral teeth and the lateral and canine teeth
- The presence of a contact point in the maxillary anterior teeth
- optimal facial keratinized gingiva/ keratinized gingiva must be more than 2mm
Key exclusion criteria (5 listed)
- pregnancy or
- breast-feeding,
- palatal and gingival recession,
- attachment loss,
- high labial frenulum.
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 |
|---|---|---|
| Concentrated Growth Factorsurgical treatment with CGF for papilla regeneration | Procedure or surgery | Concentrated Growth Factor |
Primary outcome
change in the percentage of papillary fill(PF)
Time frame: Change from 3 months percentage of papillary fill at 6 months
The percentage of PF was also calculated as ([ Lost Papillary area(PA) preoperation - PA postoperation] / PA preoperation) x 100%.
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 30 Jul 2019.
- Individual participant dataSharing planned: No
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.
zeynep Turgut Çankaya, PhD,Dr principal investigator
Gazi University, Faculty of Dentistry,Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated Growth Factor in people with Papilla, Dentinal; Calcification, run by Gazi 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 3 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 30 Jul 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?
change in the percentage of papillary fill(PF) (time frame: Change from 3 months percentage of papillary fill at 6 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 30 Jul 2019.