Periodontal DiseaseNCT03816930
Evaluation of Gingival Health Parameters in Hybrid CAD / CAM Crowns Produced After Different Retraction Processes
A study testing mechanical cord usage in people with Periodontal Disease and Gingival Disease, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Clinically, the gingival retraction dentistry itself has found wide uses. It has achieved the use of subgingival and gingival crowns in fixed prostheses, cervical abrasion in restorative dentistry, management of root caries and root sensitivity, and recently in the use of appropriate measurements to improve the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Gingival Disease
- What is being tested?
- mechanical cord usage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2019to 17 Apr 2020
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being systemically healthy
- To indicate crown restoration in mandibular molar teeth
- To be vital to the preparation of the crown of the teeth
Who cannot join
- Systemically unhealthy individuals
- Endodontic treatment of mandibular molar teeth
- Mandibular molar female individuals drawn for various reasons
- Pregnant women
- Periodontally unhealthy individuals
Trial locations and contacts
1 site in 1 country.
About this study
Clinically, the gingival retraction dentistry itself has found wide uses. It has achieved the use of subgingival and gingival crowns in fixed prostheses, cervical abrasion in restorative dentistry, management of root caries and root sensitivity, and recently in the use of appropriate measurements to improve the marginal fit of implant prostheses.There are three different retraction procedures described in the literature: mechanical, mechanical-chemical (chemically impregnated cords or matrix in injectable form) and surgery (electrosurgical, laser, cauterization, etc.)The mechanical method of retraction cords is not always suitable for patients' existing pocket depth, the necessity of using different combinations in shallow or deep pockets, the potential for limited bleeding control in chemically impregnated cords and the toxicity values in those who interact with chemical have led researchers to search for alternative methods. Especially inflammed gingiva is very sensitive to mechanical and chemical trauma. Studies have reported that gingival inflammation, pain, pocket formation, gingival withdrawal, increased bleeding and wound contamination occurred following retraction cord application. However, it is a known fact that the impression material is distorted or the accuracy of the measurement is decreased with the measurements taken without retraction. Nowadays, CAD / CAM (computer-aided design / computer-aided manufacturing) devices, which are designed to overcome these problems and eliminate the errors related to the measurement material, are the first step to be taken with a clear measure.Gingival retraction is recommended to improve the success of scanners in all restorations performed at the gingival or subgingival endpoint. Therefore, in our study, crown restorations will be produced from hybrid blocks by means of CAD / CAM device in order to evaluate the interaction of gingival health with hybrid blocks and to provide the latest technology and standardization.
- Conditions
- Periodontal Disease, Gingival Disease
- Being tested
- mechanical cord usage
- Keywords
- CAD/CAM, Gingival retraction
- Medical subject headings
- Periodontal Diseases, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical cord usageProcedure or surgery
Also called Chemical contained retraction usage, MZ-6 laser tip used throughing
Due to the retraction procedures, same preparation conditions will be obtained.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical cord usage | Active comparator | Mechanical retraction Receives: Procedure: mechanical cord usage |
| Chemical contained retraction usage | Active comparator | Chemical retraction Receives: Procedure: mechanical cord usage |
| MZ-6 laser tip used throughing | Active comparator | Laser retraction Receives: Procedure: mechanical cord usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retraction methods or procedures effects on gingival health
Probing depth is one of the criteria that shows the gingival health. In each control sessions same researcher measure the probing depth as mm via a periodontal probe.
Measured: 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start17 Jan 2019
- Primary completion17 Jan 2020
- Study completion17 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Ünalan Değirmenci, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816930
- Sponsor's protocol ID
- 05
- Status last verified
- Apr 2021
- First submitted
- 17 Jan 2019
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Padbury A Jr, Eber R, Wang HL. Interactions between the gingiva and the margin of restorations. J Clin Periodontol. 2003 May;30(5):379-85. doi: 10.1034/j.1600-051x.2003.01277.x.
PubMed 12716328Al-Ani A, Bennani V, Chandler NP, Lyons KM, Thomson WM. New Zealand dentists' use of gingival retraction techniques for fixed prosthodontics and implants. N Z Dent J. 2010 Sep;106(3):92-6.
PubMed 20882737Goldberg PV, Higginbottom FL, Wilson TG. Periodontal considerations in restorative and implant therapy. Periodontol 2000. 2001;25:100-9. doi: 10.1034/j.1600-0757.2001.22250108.x.
PubMed 11155185Kopac I, Cvetko E, Marion L. Gingival inflammatory response induced by chemical retraction agents in beagle dogs. Int J Prosthodont. 2002 Jan-Feb;15(1):14-9.
PubMed 11887594Polat NT, Ozdemir AK, Turgut M. Effects of gingival retraction materials on gingival blood flow. Int J Prosthodont. 2007 Jan-Feb;20(1):57-62.
PubMed 17319365Ferrari M, Cagidiaco MC, Ercoli C. Tissue management with a new gingival retraction material: a preliminary clinical report. J Prosthet Dent. 1996 Mar;75(3):242-7. doi: 10.1016/s0022-3913(96)90479-5.
PubMed 8648569de Gennaro GG, Landesman HM, Calhoun JE, Martinoff JT. A comparison of gingival inflammation related to retraction cords. J Prosthet Dent. 1982 Apr;47(4):384-6. doi: 10.1016/s0022-3913(82)80085-1.
PubMed 6951037Ahmed SN, Donovan TE. Gingival displacement: Survey results of dentists' practice procedures. J Prosthet Dent. 2015 Jul;114(1):81-5.e1-2. doi: 10.1016/j.prosdent.2014.11.015. Epub 2015 Apr 24.
PubMed 25917854
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gingival Health Parameters in Hybrid CAD / CAM Crowns Produced After Different Retraction Processes
- ClinicalTrials.gov ID
- NCT03816930
- Acronym / sponsor ID
- 05
- Conditions
- Periodontal Disease, Gingival Disease
- Keywords
- CAD/CAM, Gingival retraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Apr 2020 (actual)
- First posted
- 25 Jan 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.
Clinically, the gingival retraction dentistry itself has found wide uses. It has achieved the use of subgingival and gingival crowns in fixed prostheses, cervical abrasion in restorative dentistry, management of root caries and root sensitivity, and recently in the use of appropriate measurements to improve the marginal fit of implant prostheses.There are three different retraction procedures described in the literature: mechanical, mechanical-chemical (chemically impregnated cords or matrix in injectable form) and surgery (electrosurgical, laser, cauterization, etc.)The mechanical method of retraction cords is not always suitable for patients' existing pocket depth, the necessity of using different combinations in shallow or deep pockets, the potential for limited bleeding control in chemically impregnated cords and the toxicity values in those who interact with chemical have led researchers to search for alternative methods. Especially inflammed gingiva is very sensitive to mechanical and chemical trauma. Studies have reported that gingival inflammation, pain, pocket formation, gingival withdrawal, increased bleeding and wound contamination occurred following retraction cord application. However, it is a known fact that the impression material is distorted or the accuracy of the measurement is decreased with the measurements taken without retraction. Nowadays, CAD / CAM (computer-aided design / computer-aided manufacturing) devices, which are designed to overcome these problems and eliminate the errors related to the measurement material, are the first step to be taken with a clear measure.Gingival retraction is recommended to improve the success of scanners in all restorations performed at the gingival or subgingival endpoint. Therefore, in our study, crown restorations will be produced from hybrid blocks by means of CAD / CAM device in order to evaluate the interaction of gingival health with hybrid blocks and to provide the latest technology and standardization.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mechanical cord usage | Active comparator | Procedure: mechanical cord usageMechanical retraction |
| Chemical contained retraction usage | Active comparator | Procedure: mechanical cord usageChemical retraction |
| MZ-6 laser tip used throughing | Active comparator | Procedure: mechanical cord usageLaser retraction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being systemically healthy
- To indicate crown restoration in mandibular molar teeth
- To be vital to the preparation of the crown of the teeth
Key exclusion criteria (5 listed)
- Systemically unhealthy individuals
- Endodontic treatment of mandibular molar teeth
- Mandibular molar female individuals drawn for various reasons
- Pregnant women
- Periodontally unhealthy individuals
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 |
|---|---|---|
| mechanical cord usageAlso: Chemical contained retraction usage, MZ-6 laser tip used throughingDue to the retraction procedures, same preparation conditions will be obtained. | Procedure or surgery | Chemical contained retraction usage, MZ-6 laser tip used throughing, Mechanical cord usage |
Primary outcome
Retraction methods or procedures effects on gingival health
Time frame: 3-12 months
Probing depth is one of the criteria that shows the gingival health. In each control sessions same researcher measure the probing depth as mm via a periodontal probe.
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 22 Apr 2021.
- Results publication: PubMed 12716328Padbury A Jr, Eber R, Wang HL. Interactions between the gingiva and the margin of restorations. J Clin Periodontol. 2003 May;30(5):379-85. doi: 10.1034/j.1600-051x.2003.01277.x.
- Results publication: PubMed 20882737Al-Ani A, Bennani V, Chandler NP, Lyons KM, Thomson WM. New Zealand dentists' use of gingival retraction techniques for fixed prosthodontics and implants. N Z Dent J. 2010 Sep;106(3):92-6.
- Results publication: PubMed 11155185Goldberg PV, Higginbottom FL, Wilson TG. Periodontal considerations in restorative and implant therapy. Periodontol 2000. 2001;25:100-9. doi: 10.1034/j.1600-0757.2001.22250108.x.
- Results publication: PubMed 11887594Kopac I, Cvetko E, Marion L. Gingival inflammatory response induced by chemical retraction agents in beagle dogs. Int J Prosthodont. 2002 Jan-Feb;15(1):14-9.
- Results publication: PubMed 17319365Polat NT, Ozdemir AK, Turgut M. Effects of gingival retraction materials on gingival blood flow. Int J Prosthodont. 2007 Jan-Feb;20(1):57-62.
- Results publication: PubMed 8648569Ferrari M, Cagidiaco MC, Ercoli C. Tissue management with a new gingival retraction material: a preliminary clinical report. J Prosthet Dent. 1996 Mar;75(3):242-7. doi: 10.1016/s0022-3913(96)90479-5.
- Results publication: PubMed 6951037de Gennaro GG, Landesman HM, Calhoun JE, Martinoff JT. A comparison of gingival inflammation related to retraction cords. J Prosthet Dent. 1982 Apr;47(4):384-6. doi: 10.1016/s0022-3913(82)80085-1.
- Results publication: PubMed 25917854Ahmed SN, Donovan TE. Gingival displacement: Survey results of dentists' practice procedures. J Prosthet Dent. 2015 Jul;114(1):81-5.e1-2. doi: 10.1016/j.prosdent.2014.11.015. Epub 2015 Apr 24.
- Individual participant dataSharing planned: Undecided
Related trials for Periodontal Disease
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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 mechanical cord usage in people with Periodontal Disease and Gingival Disease, run by Yuzuncu Yil 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 22 Apr 2021. 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?
Retraction methods or procedures effects on gingival health (time frame: 3-12 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 NCT03816930, which also lists 8 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 22 Apr 2021.