Periodontitis ComplexNCT04227964
Periodontal Regeneration Versus Tooth Extraction and Replacement Denture in Teeth With Periodontal Hopeless Prognosis
A study testing Enamel matrix derivative, bone replacement graft, barrier membrane and Tooth extraction and replacement in people with Periodontitis Complex, run by The European Research Group on Periodontology (ERGOPerio) at 1 site in Hong Kong.
Trial summary
Periodontal regeneration can change tooth prognosis and represents an alternative to extraction in teeth compromised by severe intrabony defects. The aim of this study is to compare periodontal regeneration (PR) with tooth extraction and replacement (TER) in a population with attachment loss to or beyond the apex of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periodontitis Complex
- What is being tested?
- Enamel matrix derivative, bone replacement graft, barrier membrane and Tooth extraction and replacement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 1998to 31 Dec 2014
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Good general health
- Non-smokers or smokers with less than 20/day
- Good oral hygiene (FMPS<25%)
- Good control of periodontitis (FMBS<25%)
- Good compliance with treatment
- Presence of generalised stage III or IV periodontitis
Show all 11Show fewer
- Radiographic bone loss to the apex or beyond the apex of the root at at least one interdental aspect
- Presence of severe clinical attachment level loss (>10 mm)
- Presence of clearly identifiable crest of bone in adjacent teeth
- Lack of function due to hyper mobility
- Vital or non-vital teeth
Who cannot join
- Medical contraindication to elective surgery
- Poor oral hygiene
- Incomplete control of periodontitis in the dentition
- Inadequate compliance
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periodontal Regeneration vs Extraction and Replacement of Teeth Severely Compromised by Attachment Loss to the Apex: a 10-year RCT
Periodontal regeneration can change tooth prognosis and represents an alternative to extraction in teeth compromised by severe intrabony defects. The aim of this study is to compare periodontal regeneration (PR) with tooth extraction and replacement (TER) in a population with attachment loss to or beyond the apex of the root in terms of professional, patient reported and economic outcomes.
Read the detailed description
This was a single center 10-year randomized controlled clinical trial. 50 stage III or IV periodontitis subjects with a severely compromised tooth with attachment loss to or beyond the apex were randomized to PR or TER with either an implant or a tooth supported fixed partial denture. Subjects were kept on a strict periodontal supportive care regimen every 3 months and examined yearly. Survival, complication free survival, recurrence analysis, oral health related quality of life and patient reported outcomes analyses will be performed.
- Conditions
- Periodontitis Complex
- Being tested
- Enamel matrix derivative, bone replacement graft, barrier membrane, Tooth extraction and replacement
- Keywords
- periodontitis, periodontal regeneration, tooth extraction, dental implant, fixed partial denture, survival analysis, Complication free survival, Recurrence analysis, Oral health related quality of life
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enamel matrix derivative, bone replacement graft, barrier membraneDevice
Tooth extraction and replacementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Periodontal regeneration | Experimental | Periodontal regeneration consisting of papilla preservation flaps, application of FDA approved CE marked periodontal regenerative devices, tooth splinting and root canal treatment as required. Receives: Device: Enamel matrix derivative, bone replacement graft, barrier membrane |
| Extraction and tooth replacement | Active comparator | Tooth extraction and replacement with a dental implant or a fixed partial denture following healing and reconstruction of the extraction area. Choice based on standard of practice. Receives: Procedure: Tooth extraction and replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth or tooth replacement survival
Presence of functional and symptoms free tooth or tooth replacement
Measured: 10 year
Occurrence and cost of management of recurrence
Recurrence analysis
Measured: 10-year
Oral health related quality of life: OHIP-14 (Oral Health Impact Profile)
14 validated questions, 5 point Liker scale, smaller scores represent better outcome (smaller impact on quality of life)
Measured: 10 years
Secondary outcomes (2)
Clinical attachment level gain
Control outcome of periodontal regeneration
Measured: 10 years
Probing pocket depth
Control outcome of periodontal regeneration
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Jun 1998
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontitis ComplexStudies 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
- Model description
- Single center RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The European Research Group on Periodontology (ERGOPerio)
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pierpaolo Cortellini, MD, Study director, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227964
- Sponsor's protocol ID
- ATRO1998
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cortellini P, Stalpers G, Mollo A, Tonetti MS. Periodontal regeneration versus extraction and dental implant or prosthetic replacement of teeth severely compromised by attachment loss to the apex: A randomized controlled clinical trial reporting 10-year outcomes, survival analysis and mean cumulative cost of recurrence. J Clin Periodontol. 2020 Jun;47(6):768-776. doi: 10.1111/jcpe.13289. Epub 2020 Apr 19.
PubMed 32249446
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Regeneration vs Extraction and Replacement of Teeth Severely Compromised by Attachment Loss to the Apex: a 10-year RCT
- ClinicalTrials.gov ID
- NCT04227964
- Acronym / sponsor ID
- ATRO1998
- Conditions
- Periodontitis Complex
- Keywords
- periodontitis, periodontal regeneration, tooth extraction, dental implant, fixed partial denture, survival analysis, Complication free survival, Recurrence analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The European Research Group on Periodontology (ERGOPerio)Research network
- Study start
- 1 Jun 1998 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 14 Jan 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.
Periodontal regeneration can change tooth prognosis and represents an alternative to extraction in teeth compromised by severe intrabony defects. The aim of this study is to compare periodontal regeneration (PR) with tooth extraction and replacement (TER) in a population with attachment loss to or beyond the apex of the root in terms of professional, patient reported and economic outcomes.
Detailed description
This was a single center 10-year randomized controlled clinical trial. 50 stage III or IV periodontitis subjects with a severely compromised tooth with attachment loss to or beyond the apex were randomized to PR or TER with either an implant or a tooth supported fixed partial denture. Subjects were kept on a strict periodontal supportive care regimen every 3 months and examined yearly. Survival, complication free survival, recurrence analysis, oral health related quality of life and patient reported outcomes analyses will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single center RCT
| Arm | Type | Receives |
|---|---|---|
| Periodontal regeneration | Experimental | Device: Enamel matrix derivative, bone replacement graft, barrier membranePeriodontal regeneration consisting of papilla preservation flaps, application of FDA approved CE marked periodontal regenerative devices, tooth splinting and root canal treatment as required. |
| Extraction and tooth replacement | Active comparator | Procedure: Tooth extraction and replacementTooth extraction and replacement with a dental implant or a fixed partial denture following healing and reconstruction of the extraction area. Choice based on standard of practice. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Good general health
- Non-smokers or smokers with less than 20/day
- Good oral hygiene (FMPS<25%)
- Good control of periodontitis (FMBS<25%)
- Good compliance with treatment
Key exclusion criteria (5 listed)
- Medical contraindication to elective surgery
- Poor oral hygiene
- Incomplete control of periodontitis in the dentition
- Inadequate compliance
- Inability to provide informed consent
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 |
|---|---|---|
| Enamel matrix derivative, bone replacement graft, barrier membrane | Device | Periodontal regeneration |
| Tooth extraction and replacement | Procedure or surgery | Extraction and tooth replacement |
Primary outcome
Tooth or tooth replacement survival
Time frame: 10 year
Presence of functional and symptoms free tooth or tooth replacement
Occurrence and cost of management of recurrence
Time frame: 10-year
Recurrence analysis
Oral health related quality of life: OHIP-14 (Oral Health Impact Profile)
Time frame: 10 years
14 validated questions, 5 point Liker scale, smaller scores represent better outcome (smaller impact on quality of life)
2 secondary outcomes
Clinical attachment level gain
Time frame: 10 years
Probing pocket depth
Time frame: 10 years
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 Jan 2020.
- Derived from this study: PubMed 32249446Cortellini P, Stalpers G, Mollo A, Tonetti MS. Periodontal regeneration versus extraction and dental implant or prosthetic replacement of teeth severely compromised by attachment loss to the apex: A randomized controlled clinical trial reporting 10-year outcomes, survival analysis and mean cumulative cost of recurrence. J Clin Periodontol. 2020 Jun;47(6):768-776. doi: 10.1111/jcpe.13289. Epub 2020 Apr 19.
- Individual participant dataSharing planned: No
Related trials for Periodontitis Complex
Not yet recruitingObservational study
Klotho Gene, Red Complex Bacteria and Periodontal Viruses in Patients With and Without Periodontitis and Acute Coronary Syndrome
Periodontal Diseases, Acute Coronary Artery Disease
RecruitingObservational study
Periodontal Disease in Rare Renal Disorders (PERIO-RA-RE)
Periodontal Disease, Periodontitis
Recruiting
A Chitosan Brush and Enamel Matrix Derivative for Non-surgical Treatment of Furcations
Periodontitis, Adult, Furcation Defects
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.
Pierpaolo Cortellini, MD study director
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enamel matrix derivative, bone replacement graft, barrier membrane and Tooth extraction and replacement in people with Periodontitis Complex, run by The European Research Group on Periodontology (ERGOPerio) at 1 site in Hong Kong.
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 11 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 14 Jan 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 Hong Kong. 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?
Tooth or tooth replacement survival (time frame: 10 year). The study lists 3 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 NCT04227964, which also lists 1 linked publication.
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 Jan 2020.