Periodontal RegenerationNCT05922527
Amnion Chorion Membrane Combined With Allograft Bone Putty for the Management of Intrabony Defects
A study testing Combined regenerative technique and Open flap debridement in people with Periodontal Regeneration, run by Cairo University at 1 site in Egypt.
Trial summary
The ultimate goal for periodontal management is to obtain true periodontal regeneration. Periodontal regeneration implies that CAL gain is achieved through the formation of new cementum and new inserted periodontal ligaments, accompanied by alveolar bone formation, thus a whole new periodontal apparatus is… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Regeneration
- What is being tested?
- Combined regenerative technique and Open flap debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 20 Aug 2022
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mature permanent tooth.
- Tooth with two or three-walled intra-bony defect, PPD ≥ 5mm with intra osseous defect ≥ 3mm.
- Good oral hygiene.
- Compliance with the maintenance program.
- Accepted the 6 months follow-up period.
Who cannot join
- Teeth with one wall intra-bony defect or supra-bony defects.
- Teeth with grade II or III mobility.
- Teeth with proximal carious defects or proximal faulty restorations.
- Medically compromised patients.
- Pregnant or nursing women.
- Smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Using Amnion Chorion Membrane Combined With Allograft Bone Putty for the Management of Intrabony Defects in Patients With Chronic Periodontitis: a Randomized Clinical Trial
The ultimate goal for periodontal management is to obtain true periodontal regeneration. Periodontal regeneration implies that CAL gain is achieved through the formation of new cementum and new inserted periodontal ligaments, accompanied by alveolar bone formation, thus a whole new periodontal apparatus is reconstructed. Combined periodontal regenerative therapy; including bone grafting are considered a viable treatment option and result in significantly better clinical outcomes in intrabony defects compared to monotherapy.
This study was conducted as a randomized controlled clinical trial to evaluate clinically and radiographically the possible predictable results regarding the use of amnion chorion allograft (ACM) barrier and demineralized freeze dried bone allograft, (DFDBA) versus open flap debridement (OFD) in treatment of periodontal intrabony defects.
Read the detailed description
True periodontal regeneration is the ultimate goal for periodontal management, implies that clinical attachment level gain is achieved through the formation of new cementum and new inserted periodontal ligaments, accompanied by alveolar bone formation, thus a whole new periodontal apparatus is reconstructed. Various techniques and biomaterials have been used to achieve periodontal regeneration of intraosseous defects.
In order to compare the effectiveness of various periodontal regenerative therapies in treating periodontal infrabony defects many systematic reviews were carried out. The use of guided tissue regeneration (GTR) and the combined therapies as regenerative approaches were shown to be more effective than flap procedures, nonetheless, the differences between regenerative therapies to be minor and insignificant.
Amnion chorion placental derived membrane (ACM) has been introduced in periodontal regenerative therapy owing to its biological properties. It is biocompatible, biodegradable and promotes proliferation and migration of the adjacent autogenous connective tissue. There is no single reported incidence of graft rejection, disease transmission or immune response from using placental tissues since its first documented usage till today. ACM has been used in many surgical dental procedures as GTR, alveolar bone preservation and guided bone regeneration. ACM possesses unique features that make it different from other materials used in this fields. In periodontal regenerative procedures as GTR, ACM assists rapid epithelial cell growth instead of epithelial cells exclusion as for the traditional concept of GTR. As epithelial cells are encouraged to migrate rapidly across the ACM barrier, they form an epithelial seal over the underlying bone graft or bony defect space and do not apically migrate into the defect .
Several studies support the use of ACM as an effective material alternative to the currently used materials/techniques for periodontal regeneration procedures, however more well conducted studies are still needed.
Accordingly, numerous data and researches are available nowadays, which support the great and variant regenerative capacities of the different periodontal biomaterials that are widely available and currently used for treatment of periodontal intra-bony defects, especially DFDBA and ACM. However, minimal radiographic findings were mentioned in the previous systematic reviews comparing combined regenerative approach and OFD.
- Conditions
- Periodontal Regeneration
- Being tested
- Combined regenerative technique, Open flap debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined regenerative techniqueProcedure or surgery
Periodontal regenerative technique using amnion chorion membrane combined with DFDBA in a putty form
Open flap debridementProcedure or surgery
Open flap debridement
| Study group | Role | What they receive |
|---|---|---|
| Combined regenerative technique | Experimental | Open flap debridement combined with Amnion Chorion Membrane and DFDBA Receives: Procedure: Combined regenerative technique |
| Open flap debridement | Active comparator | Open flap debridement Receives: Procedure: Open flap debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level gain
clinical attachment level gain intragroup and intergroup, measured clinically in mm using periodontal probe
Measured: 6 months
Secondary outcomes (2)
Probing Pocket Depth Change
Probing pocket depth change, measured clinically in mm using periodontal probe
Measured: 6 months
Bone defect area
bone defect area, measured radiographically in mm3 using periapical radiographs
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 posted28 Jun 2023
- Study start1 Sep 2021
- Primary completion1 Jul 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal RegenerationStudies of the same condition, open and under way.
- More trials run by Cairo 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, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Samy Abdelmalak Hanna, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922527
- Sponsor's protocol ID
- PERIO2:5:1
- Status last verified
- Aug 2023
- First submitted
- 7 Jun 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Using Amnion Chorion Membrane Combined With Allograft Bone Putty for the Management of Intrabony Defects in Patients With Chronic Periodontitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05922527
- Acronym / sponsor ID
- PERIO2:5:1
- Conditions
- Periodontal Regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 28 Jun 2023 (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 ultimate goal for periodontal management is to obtain true periodontal regeneration. Periodontal regeneration implies that CAL gain is achieved through the formation of new cementum and new inserted periodontal ligaments, accompanied by alveolar bone formation, thus a whole new periodontal apparatus is reconstructed. Combined periodontal regenerative therapy; including bone grafting are considered a viable treatment option and result in significantly better clinical outcomes in intrabony defects compared to monotherapy.
This study was conducted as a randomized controlled clinical trial to evaluate clinically and radiographically the possible predictable results regarding the use of amnion chorion allograft (ACM) barrier and demineralized freeze dried bone allograft, (DFDBA) versus open flap debridement (OFD) in treatment of periodontal intrabony defects.
Detailed description
True periodontal regeneration is the ultimate goal for periodontal management, implies that clinical attachment level gain is achieved through the formation of new cementum and new inserted periodontal ligaments, accompanied by alveolar bone formation, thus a whole new periodontal apparatus is reconstructed. Various techniques and biomaterials have been used to achieve periodontal regeneration of intraosseous defects.
In order to compare the effectiveness of various periodontal regenerative therapies in treating periodontal infrabony defects many systematic reviews were carried out. The use of guided tissue regeneration (GTR) and the combined therapies as regenerative approaches were shown to be more effective than flap procedures, nonetheless, the differences between regenerative therapies to be minor and insignificant.
Amnion chorion placental derived membrane (ACM) has been introduced in periodontal regenerative therapy owing to its biological properties. It is biocompatible, biodegradable and promotes proliferation and migration of the adjacent autogenous connective tissue. There is no single reported incidence of graft rejection, disease transmission or immune response from using placental tissues since its first documented usage till today. ACM has been used in many surgical dental procedures as GTR, alveolar bone preservation and guided bone regeneration. ACM possesses unique features that make it different from other materials used in this fields. In periodontal regenerative procedures as GTR, ACM assists rapid epithelial cell growth instead of epithelial cells exclusion as for the traditional concept of GTR. As epithelial cells are encouraged to migrate rapidly across the ACM barrier, they form an epithelial seal over the underlying bone graft or bony defect space and do not apically migrate into the defect .
Several studies support the use of ACM as an effective material alternative to the currently used materials/techniques for periodontal regeneration procedures, however more well conducted studies are still needed.
Accordingly, numerous data and researches are available nowadays, which support the great and variant regenerative capacities of the different periodontal biomaterials that are widely available and currently used for treatment of periodontal intra-bony defects, especially DFDBA and ACM. However, minimal radiographic findings were mentioned in the previous systematic reviews comparing combined regenerative approach and OFD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined regenerative technique | Experimental | Procedure: Combined regenerative techniqueOpen flap debridement combined with Amnion Chorion Membrane and DFDBA |
| Open flap debridement | Active comparator | Procedure: Open flap debridementOpen flap debridement |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mature permanent tooth.
- Tooth with two or three-walled intra-bony defect, PPD ≥ 5mm with intra osseous defect ≥ 3mm.
- Good oral hygiene.
- Compliance with the maintenance program.
- Accepted the 6 months follow-up period.
Key exclusion criteria (6 listed)
- Teeth with one wall intra-bony defect or supra-bony defects.
- Teeth with grade II or III mobility.
- Teeth with proximal carious defects or proximal faulty restorations.
- Medically compromised patients.
- Pregnant or nursing women.
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 |
|---|---|---|
| Combined regenerative techniquePeriodontal regenerative technique using amnion chorion membrane combined with DFDBA in a putty form | Procedure or surgery | Combined regenerative technique |
| Open flap debridementOpen flap debridement | Procedure or surgery | Open flap debridement |
Primary outcome
Clinical attachment level gain
Time frame: 6 months
clinical attachment level gain intragroup and intergroup, measured clinically in mm using periodontal probe
2 secondary outcomes
Probing Pocket Depth Change
Time frame: 6 months
Bone defect area
Time frame: 6 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 16 Aug 2023.
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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.
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 Combined regenerative technique and Open flap debridement in people with Periodontal Regeneration, run by Cairo University 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 5 inclusion and 6 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 16 Aug 2023. 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. 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?
Clinical attachment level gain (time frame: 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 16 Aug 2023.