Dental ImplantsNCT04305080
Effect of Anodic Oxidation of Implant Abutment Collar on the Peri-implant Soft Tissue Health
A study testing Anodic oxidation and Untreated abutment in people with Dental Implants, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
This research aims to evaluate the effect of anodic oxidation of implant abutment collar on the peri-implant soft tissue health. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Dental Implants
- What is being tested?
- Anodic oxidation and Untreated abutment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2019to 7 Oct 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy patients with good oral hygiene.
- Having two inserted dental implants in the same quadrant with healing abutments.
- Implants with at least 1 mm peri-implant soft tissue height.
Who cannot join
- Patients with systemic conditions interfering with soft tissue health.
- Heavy smoking.
- Patients with inflamed gingival tissue or bad oral hygiene.
- Diseased gingival tissue that needs periodontal treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Anodic Oxidation of Implant Abutment Collar on the Peri-implant Soft Tissue Health (Randomized Controlled Clinical Trial)
This research aims to evaluate the effect of anodic oxidation of implant abutment collar on the peri-implant soft tissue health.
Read the detailed description
A randomized controlled clinical trial will be implemented on 10 implant abutments in five patients, each having 2 dental implants in the same quadrant. Abutments with standard silver collars will be divided into two groups: Group 1 (test group) will undergo anodic oxidation of the abutment collar changing it into pink color. Group 2 (control group) untreated abutments.
- Conditions
- Dental Implants
- Being tested
- Anodic oxidation, Untreated abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodic oxidationOther
Abutments will undergo anodic oxidation process after etching with Hydrofluoric acid \& Nitric acid mixture for 10 minutes for debridement in a bath of distilled water with citric acid for 5 minutes to turn the abutment collar into pink color. The stainless steel plate will be connected to the cathode (-) and titanium abutments will be connected to the anode (+) end of the DC Power Supply. After then abutments will be left in distilled water for 10 minutes and sterilized before insertion in patient mouth.
Untreated abutmentOther
Abutment will be left untreated with its gray color.
| Study group | Role | What they receive |
|---|---|---|
| Anodic Oxidation of implant abutment | Experimental | Not described Receives: Other: Anodic oxidation |
| Untreated implant abutment | Sham comparator | Not described Receives: Other: Untreated abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink aesthetic score
Each variable will be assessed using the 0-2 scoring; with 2 being the highest score and 0 the lowest score. The highest possible score is 14 reflecting a peri-implant tissue that is most similar to the soft tissues of the reference tooth. The mesial and distal papillae will be assessed as complete, incomplete, or absent.
Measured: baseline
Pink aesthetic score
Each variable will be assessed using the 0-2 scoring; with 2 being the highest score and 0 the lowest score. The highest possible score is 14 reflecting a peri-implant tissue that is most similar to the soft tissues of the reference tooth. The mesial and distal papillae will be assessed as complete, incomplete, or absent.
Measured: 6 months
Plaque index (Silness-Löe Index)
This will be assessed on 4 surfaces of 6 index teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth are added and divided by four in order to give the plaque index for the tooth with the following scores and criteria. 0:No plaque, 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: baseline
Plaque index (Silness-Löe Index)
This will be assessed on 4 surfaces of 6 index teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth are added and divided by four in order to give the plaque index for the tooth with the following scores and criteria. 0:No plaque, 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Measured: 6 months
Probing depth
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Measured: baseline
Probing depth
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Measured: 6 months
Bleeding on probing
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Measured: baseline
Bleeding on probing
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start20 Oct 2019
- Primary completion15 Aug 2020
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Khaled Farrag, BDS, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptMoataz Khamis, PhD, Study chair, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305080
- Sponsor's protocol ID
- Anodic oxidation
- Status last verified
- Oct 2020
- First submitted
- 9 Mar 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gehrke P, Lobert M, Dhom G. Reproducibility of the pink esthetic score--rating soft tissue esthetics around single-implant restorations with regard to dental observer specialization. J Esthet Restor Dent. 2008;20(6):375-84; discussion 385. doi: 10.1111/j.1708-8240.2008.00212.x.
PubMed 19120783Diamanti MV, Del Curto B, Pedeferri M. Anodic oxidation of titanium: from technical aspects to biomedical applications. J Appl Biomater Biomech. 2011 Jan-Apr;9(1):55-69. doi: 10.5301/JABB.2011.7429.
PubMed 21607937Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
PubMed 16307569
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anodic Oxidation of Implant Abutment Collar on the Peri-implant Soft Tissue Health (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04305080
- Acronym / sponsor ID
- Anodic oxidation
- Conditions
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 12 Mar 2020 (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 research aims to evaluate the effect of anodic oxidation of implant abutment collar on the peri-implant soft tissue health.
Detailed description
A randomized controlled clinical trial will be implemented on 10 implant abutments in five patients, each having 2 dental implants in the same quadrant. Abutments with standard silver collars will be divided into two groups: Group 1 (test group) will undergo anodic oxidation of the abutment collar changing it into pink color. Group 2 (control group) untreated abutments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodic Oxidation of implant abutment | Experimental | Other: Anodic oxidation |
| Untreated implant abutment | Sham comparator | Other: Untreated abutment |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy patients with good oral hygiene.
- Having two inserted dental implants in the same quadrant with healing abutments.
- Implants with at least 1 mm peri-implant soft tissue height.
Key exclusion criteria (4 listed)
- Patients with systemic conditions interfering with soft tissue health.
- Heavy smoking.
- Patients with inflamed gingival tissue or bad oral hygiene.
- Diseased gingival tissue that needs periodontal treatment.
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 |
|---|---|---|
| Anodic oxidationAbutments will undergo anodic oxidation process after etching with Hydrofluoric acid \& Nitric acid mixture for 10 minutes for debridement in a bath of distilled water with citric acid for 5 minutes to turn the abutment collar into pink color. The stainless steel plate will be connected to the cathode (-) and titanium abutments will be connected to the anode (+) end of the DC Power Supply. After then abutments will be left in distilled water for 10 minutes and sterilized before insertion in patient mouth. | Other | Anodic Oxidation of implant abutment |
| Untreated abutmentAbutment will be left untreated with its gray color. | Other | Untreated implant abutment |
Primary outcome
Pink aesthetic score
Time frame: baseline
Each variable will be assessed using the 0-2 scoring; with 2 being the highest score and 0 the lowest score. The highest possible score is 14 reflecting a peri-implant tissue that is most similar to the soft tissues of the reference tooth. The mesial and distal papillae will be assessed as complete, incomplete, or absent.
Pink aesthetic score
Time frame: 6 months
Each variable will be assessed using the 0-2 scoring; with 2 being the highest score and 0 the lowest score. The highest possible score is 14 reflecting a peri-implant tissue that is most similar to the soft tissues of the reference tooth. The mesial and distal papillae will be assessed as complete, incomplete, or absent.
Plaque index (Silness-Löe Index)
Time frame: baseline
This will be assessed on 4 surfaces of 6 index teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth are added and divided by four in order to give the plaque index for the tooth with the following scores and criteria. 0:No plaque, 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Plaque index (Silness-Löe Index)
Time frame: 6 months
This will be assessed on 4 surfaces of 6 index teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth are added and divided by four in order to give the plaque index for the tooth with the following scores and criteria. 0:No plaque, 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. 2: Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. 3: Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Probing depth
Time frame: baseline
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Probing depth
Time frame: 6 months
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Bleeding on probing
Time frame: baseline
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Bleeding on probing
Time frame: 6 months
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
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 14 Oct 2020.
- Background: PubMed 19120783Gehrke P, Lobert M, Dhom G. Reproducibility of the pink esthetic score--rating soft tissue esthetics around single-implant restorations with regard to dental observer specialization. J Esthet Restor Dent. 2008;20(6):375-84; discussion 385. doi: 10.1111/j.1708-8240.2008.00212.x.
- Background: PubMed 21607937Diamanti MV, Del Curto B, Pedeferri M. Anodic oxidation of titanium: from technical aspects to biomedical applications. J Appl Biomater Biomech. 2011 Jan-Apr;9(1):55-69. doi: 10.5301/JABB.2011.7429.
- Background: PubMed 16307569Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
Related trials for Dental Implants
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
RecruitingObservational study
Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants
Dental Implants
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
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.
Khaled Farrag, BDS principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Moataz Khamis, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodic oxidation and Untreated abutment in people with Dental Implants, run by Nourhan M.Aly at 1 site in Egypt.
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 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 14 Oct 2020. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Pink aesthetic score (time frame: baseline). The study lists 8 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 NCT04305080, which also lists 3 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 14 Oct 2020.