Intrabony Periodontal DefectNCT03399279
Perforated Collagen Membrane With Nanohydroxyapatite for Intrabony Defects
A study testing Open flap debridment, Perforated collagen membrane and Occlusive membrane in people with Intrabony Periodontal Defect, run by Ain Shams University.
Trial summary
The ultimate goal of periodontal therapy is the regeneration of periodontal tissues which have been destroyed due to periodontal disease. Different modalities have been proposed to obtain regeneration of periodontal tissues employing various bone grafts, bone substitute materials, guided tissue regeneration (GTR)… Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- Open flap debridment, Perforated collagen membrane and Occlusive membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 17 Dec 2014to 25 Mar 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients free from any systemic diseases as evidenced by health using Burket's Oral Medicine health history questionnaire. (Glick, 2008)
- Patients' age range from 25 to 50 years old.
- Each patient should have at least two contralateral intrabony defects which fulfill the following criteria: ** Probing depth ≥ 5 mm.
- Clinical attachment loss ≥ 5 mm.
- Radiographic evidence of vertical bone loss using periapical radiographs.
- Patients are should be willing to participate in the study and should be able to return for the follow up visits.
Who cannot join
- Patients with history of periodontal surgery or medications including antibiotics and non-steroidal anti-inflammatory drugs for at least 3 months prior to the initiation of the study.
- Pregnant females as well as breast feeding mothers.
- Smokers.
- Vulnerable groups as prisoners, mentally disabled, etc…
About this study
Official title: Comparative Study Of Perforated Versus Non Perforated Collagen Membrane Combined With Nanohydroxyapatite In The Management Of Intrabony Defects
The ultimate goal of periodontal therapy is the regeneration of periodontal tissues which have been destroyed due to periodontal disease. Different modalities have been proposed to obtain regeneration of periodontal tissues employing various bone grafts, bone substitute materials, guided tissue regeneration (GTR), combination of bone grafts or bone substitutes with GTR, and growth factors.
So, a new, fully synthetic, nanocrystalline, unsintered, phase-pure hydroxyapatite (nano-HA) has been suggested as a potential material for enhancing periodontal and bone regeneration since its chemical composition and crystalline structure correspond to the calcium phosphate component of natural bone and may have greater potential for resorption compared with sintered hydroxyapatite.
Read more
A study performed in 2012, on 14 patients with paired intrabony periodontal defects of ≥4 mm participated in split mouth design study. The defects in each subject were randomly selected to receive nano-HA paste in conjunction with papilla preservation flaps or papilla preservation flaps alone. Probing bone levels from a customized acrylic stent and probing pocket depths were measured at baseline and again 6 months following surgery. No differences in any of the investigated parameters were observed at baseline between the two groups. Healing was uneventful in all patients. Both treatments resulted in significant improvements between baseline and 6 months in all clinical and radio-graphic parameters. In conclusion, they found that the nano crystalline hydroxyapatite bone graft in combination with collagen membrane demonstrated clinical advantages beyond that achieved by open flap debridement alone.
The concept of porous guided tissue membrane has been tested recently as a modality that could stimulate bone formation of critical sized bone defects. Kim and co-workers claimed that asymmetrically porous GBR membranes with dual BMP-2 and ultrasound stimulation may be promising for the clinical treatment of delayed and insufficient bone healing. For guided tissue regeneration in periodontal therapy, membrane perforations could allow for gingival stem cells and periosteal cells to take part in supracrestal regeneration. The perforated section of the membranes would stabilize supracrestal fibrin clot through mechanical interlocking of fibrin strands with the membrane pores providing more membrane and clot stability. It has been suggested that regenerative failures may result when the tensile strength of the fibrin clot is exceeded, resulting in a tear and a long junctional epithelium type attachment.
Read the detailed description
The study will be conducted on 12 individuals. The research esthetics committee of Faculty of Dentistry, Ain Shams University will review the proposal.
All patients will be informed about the nature of the study and will fine an informed consent.
I - Selection of the patients:
The patients will be selected from the outpatient clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Ain Shams University.
All the selected patients will be selected according to following criteria:
Inclusion criteria:
- Patients free from any systemic diseases as evidenced by health using Burket's Oral Medicine health history questionnaire. (Glick, 2008)
- Patients' age range from 25 to 50 years old.
- Each patient should have at least two contralateral intrabony defects which fulfill the following criteria: (i) Probing depth ≥ 5 mm. (ii) Clinical attachment loss ≥ 5 mm. (iii) Radiographic evidence of vertical bone loss using periapical radiographs.
- Patients are should be willing to participate in the study and should be able to return for the follow up visits.
Exclusion criteria:
- Patients with history of periodontal surgery or medications including antibiotics and non-steroidal anti-inflammatory drugs for at least 3 months prior to the initiation of the study.
- Pregnant females as well as breast feeding mothers.
- Smokers.
- Vulnerable groups as prisoners, mentally disabled, etc… All participants following initial clinical examination and periapical radiographs will be given detailed instructions in self-performed plaque control measures, including tooth brushing and dental flossing. All patients will receive full mouth scaling and root planing using ultra-sonic scalers and hand instruments under local anesthesia to minimize patient discomfort.
II- Study groups:
The selected sites will be randomly "double blinded study" divided into two groups in a split mouth design.
Group One:
The defects will be treated with open flap debridment followed by the placement of nanohydroxyapetite* combined with perforated collagen membrane**.
Group Two:
The defects will be treated with open flap debridment followed by the placement of nanohydroxyapetite combined with non perforated collagen membrane.
The mucoperiosteal flaps will be adapted and sutured and the patients will be given post-surgical instructions.
III- Periodontal evaluation:
Clinical Parameters:
The clinical parameters will be measured at one, three and six months postoperatively.
- Plaque index (PI): Criteria of plaque index (PI) of (Silness and Loe, 1969) 0: No plaque in gingival area.
- No plaque visible by the unaided eye, but plaque is made visible on the point of the probe after it has been moved across surface at entrance of gingival crevice.
- Gingival area is covered with thin to moderately thick layer of plaque, deposit is visible to naked eye.
- Heavy accumulation of plaque, the thickness of which fills out niche produced by gingival margin and tooth surface, inter dental area is stuffed with plaque.
- Gingival index (GI): Criteria of the gingival index (GI) of (Loe, 1967) 0: Normal gingiva
- Mild inflammation: slight change in color and slight edema; no bleeding on probing.
- moderate inflammation: redness, edema and glazing; bleeding on probing.
- Severe inflammation: marked redness and edema; ulceration; tendency to spontaneous bleeding.
- Probing pocket depth (PPD) : Probing pocket depth (PPD) will be measured from the gingival margin to the base of periodontal pocket to the nearest mm (Caton, 1989).
Six readings will be recorded for each tooth: Mesiobuccal, mid-buccal, distobuccal, mesiolingual, mid-lingual and distolingual.
- Clinical attachment level (CAL): Clinical attachment level will be measured from cementoenamel junction to the base of pocket to the nearest mm.
B- Radiographic parameters
Periapical radiographs and Cone beam computed tomography will be taken at base line and at six months after the placement of barrier membranes combined with nanohydroxyapatite and the following parameters will be measured:
The sites will be measured first on periapical radiographs and later on CBCT with the help of the ruler in the Image Tool software (University of Texas Health Science Centre, San Antonio, TX) based on the method proposed by Misch et al.
Three measurements will be performed for each site:
- The height of the alveolar crest (AC): measured from the cementoenamel junction (CEJ) to the AC.
- The depth of the defect, measured from the CEJ to the bottom of the defect.
- The width of the defect, measured from the highest point of the AC to the dental root adjacent to the defect.
The axial slices will be used to verify the presence of combined bone defects and identify according to the classification of Goldman and Cohen.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- Open flap debridment, Perforated collagen membrane, Occlusive membrane, Nanohydroxyapetite
- Keywords
- nanohydroxyapatite, Perforated membrane, occlusive membrane, Aggressive periodontitis
- Medical subject headings
- Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open flap debridmentProcedure or surgery
Full mucoperiosteal flap reflected+ Debridement of infrabony defect
Perforated collagen membraneOther
Membrane perforations using dental needle
Occlusive membraneOther
Biotech collagen membrane
NanohydroxyapetiteOther
Nanbone Particles
| Study group | Role | What they receive |
|---|---|---|
| Open flap debridement & perforated&Nano | Experimental | Perforated collagen membrane and nano-hydroxyapatite and open flap debridement Receives: Procedure: Open flap debridment; Other: Perforated collagen membrane; Other: Nanohydroxyapetite |
| Open flap debridment &Occlusive&Nano | Active comparator | Occlusive membrane and nano-hydroxyapatite and open flap debridement Receives: Procedure: Open flap debridment; Other: Occlusive membrane; Other: Nanohydroxyapetite |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAL
Clinical attachment level
Measured: Change from base line to 3 months and 6 months
Secondary outcomes (1)
DOD
Depth of Defect (From cemento enamel junction to defect base)
Measured: Change from base line to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start17 Dec 2014
- Primary completion15 Sep 2016
- Study completion25 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony Periodontal DefectStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Mohammed Abdallah, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399279
- Sponsor's protocol ID
- 0925-0586
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Of Perforated Versus Non Perforated Collagen Membrane Combined With Nanohydroxyapatite In The Management Of Intrabony Defects
- ClinicalTrials.gov ID
- NCT03399279
- Acronym / sponsor ID
- 0925-0586
- Conditions
- Intrabony Periodontal Defect
- Keywords
- nanohydroxyapatite, Perforated membrane, occlusive membrane, Aggressive periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 17 Dec 2014 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 25 Mar 2017 (actual)
- First posted
- 16 Jan 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 ultimate goal of periodontal therapy is the regeneration of periodontal tissues which have been destroyed due to periodontal disease. Different modalities have been proposed to obtain regeneration of periodontal tissues employing various bone grafts, bone substitute materials, guided tissue regeneration (GTR), combination of bone grafts or bone substitutes with GTR, and growth factors.
So, a new, fully synthetic, nanocrystalline, unsintered, phase-pure hydroxyapatite (nano-HA) has been suggested as a potential material for enhancing periodontal and bone regeneration since its chemical composition and crystalline structure correspond to the calcium phosphate component of natural bone and may have greater potential for resorption compared with sintered hydroxyapatite.
A study performed in 2012, on 14 patients with paired intrabony periodontal defects of ≥4 mm participated in split mouth design study. The defects in each subject were randomly selected to receive nano-HA paste in conjunction with papilla preservation flaps or papilla preservation flaps alone. Probing bone levels from a customized acrylic stent and probing pocket depths were measured at baseline and again 6 months following surgery. No differences in any of the investigated parameters were observed at baseline between the two groups. Healing was uneventful in all patients. Both treatments resulted in significant improvements between baseline and 6 months in all clinical and radio-graphic parameters. In conclusion, they found that the nano crystalline hydroxyapatite bone graft in combination with collagen membrane demonstrated clinical advantages beyond that achieved by open flap debridement alone.
The concept of porous guided tissue membrane has been tested recently as a modality that could stimulate bone formation of critical sized bone defects. Kim and co-workers claimed that asymmetrically porous GBR membranes with dual BMP-2 and ultrasound stimulation may be promising for the clinical treatment of delayed and insufficient bone healing. For guided tissue regeneration in periodontal therapy, membrane perforations could allow for gingival stem cells and periosteal cells to take part in supracrestal regeneration. The perforated section of the membranes would stabilize supracrestal fibrin clot through mechanical interlocking of fibrin strands with the membrane pores providing more membrane and clot stability. It has been suggested that regenerative failures may result when the tensile strength of the fibrin clot is exceeded, resulting in a tear and a long junctional epithelium type attachment.
Detailed description
The study will be conducted on 12 individuals. The research esthetics committee of Faculty of Dentistry, Ain Shams University will review the proposal.
All patients will be informed about the nature of the study and will fine an informed consent.
I - Selection of the patients:
The patients will be selected from the outpatient clinic of Oral Medicine and Periodontology department, Faculty of Dentistry, Ain Shams University.
All the selected patients will be selected according to following criteria:
Inclusion criteria:
- Patients free from any systemic diseases as evidenced by health using Burket's Oral Medicine health history questionnaire. (Glick, 2008)
- Patients' age range from 25 to 50 years old.
- Each patient should have at least two contralateral intrabony defects which fulfill the following criteria: (i) Probing depth ≥ 5 mm. (ii) Clinical attachment loss ≥ 5 mm. (iii) Radiographic evidence of vertical bone loss using periapical radiographs.
- Patients are should be willing to participate in the study and should be able to return for the follow up visits.
Exclusion criteria:
- Patients with history of periodontal surgery or medications including antibiotics and non-steroidal anti-inflammatory drugs for at least 3 months prior to the initiation of the study.
- Pregnant females as well as breast feeding mothers.
- Smokers.
- Vulnerable groups as prisoners, mentally disabled, etc… All participants following initial clinical examination and periapical radiographs will be given detailed instructions in self-performed plaque control measures, including tooth brushing and dental flossing. All patients will receive full mouth scaling and root planing using ultra-sonic scalers and hand instruments under local anesthesia to minimize patient discomfort.
II- Study groups:
The selected sites will be randomly "double blinded study" divided into two groups in a split mouth design.
Group One:
The defects will be treated with open flap debridment followed by the placement of nanohydroxyapetite* combined with perforated collagen membrane**.
Group Two:
The defects will be treated with open flap debridment followed by the placement of nanohydroxyapetite combined with non perforated collagen membrane.
The mucoperiosteal flaps will be adapted and sutured and the patients will be given post-surgical instructions.
III- Periodontal evaluation:
Clinical Parameters:
The clinical parameters will be measured at one, three and six months postoperatively.
- Plaque index (PI): Criteria of plaque index (PI) of (Silness and Loe, 1969) 0: No plaque in gingival area.
- No plaque visible by the unaided eye, but plaque is made visible on the point of the probe after it has been moved across surface at entrance of gingival crevice.
- Gingival area is covered with thin to moderately thick layer of plaque, deposit is visible to naked eye.
- Heavy accumulation of plaque, the thickness of which fills out niche produced by gingival margin and tooth surface, inter dental area is stuffed with plaque.
- Gingival index (GI): Criteria of the gingival index (GI) of (Loe, 1967) 0: Normal gingiva
- Mild inflammation: slight change in color and slight edema; no bleeding on probing.
- moderate inflammation: redness, edema and glazing; bleeding on probing.
- Severe inflammation: marked redness and edema; ulceration; tendency to spontaneous bleeding.
- Probing pocket depth (PPD) : Probing pocket depth (PPD) will be measured from the gingival margin to the base of periodontal pocket to the nearest mm (Caton, 1989).
Six readings will be recorded for each tooth: Mesiobuccal, mid-buccal, distobuccal, mesiolingual, mid-lingual and distolingual.
- Clinical attachment level (CAL): Clinical attachment level will be measured from cementoenamel junction to the base of pocket to the nearest mm.
B- Radiographic parameters
Periapical radiographs and Cone beam computed tomography will be taken at base line and at six months after the placement of barrier membranes combined with nanohydroxyapatite and the following parameters will be measured:
The sites will be measured first on periapical radiographs and later on CBCT with the help of the ruler in the Image Tool software (University of Texas Health Science Centre, San Antonio, TX) based on the method proposed by Misch et al.
Three measurements will be performed for each site:
- The height of the alveolar crest (AC): measured from the cementoenamel junction (CEJ) to the AC.
- The depth of the defect, measured from the CEJ to the bottom of the defect.
- The width of the defect, measured from the highest point of the AC to the dental root adjacent to the defect.
The axial slices will be used to verify the presence of combined bone defects and identify according to the classification of Goldman and Cohen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open flap debridement & perforated&Nano | Experimental | Procedure: Open flap debridment, Other: Perforated collagen membrane, Other: NanohydroxyapetitePerforated collagen membrane and nano-hydroxyapatite and open flap debridement |
| Open flap debridment &Occlusive&Nano | Active comparator | Procedure: Open flap debridment, Other: Occlusive membrane, Other: NanohydroxyapetiteOcclusive membrane and nano-hydroxyapatite and open flap debridement |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients free from any systemic diseases as evidenced by health using Burket's Oral Medicine health history questionnaire. (Glick, 2008)
- Patients' age range from 25 to 50 years old.
- Each patient should have at least two contralateral intrabony defects which fulfill the following criteria: ** Probing depth ≥ 5 mm.
- Patients are should be willing to participate in the study and should be able to return for the follow up visits.
Key exclusion criteria (4 listed)
- Patients with history of periodontal surgery or medications including antibiotics and non-steroidal anti-inflammatory drugs for at least 3 months prior to the initiation of the study.
- Pregnant females as well as breast feeding mothers.
- Smokers.
- Vulnerable groups as prisoners, mentally disabled, etc…
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 |
|---|---|---|
| Open flap debridmentFull mucoperiosteal flap reflected+ Debridement of infrabony defect | Procedure or surgery | Open flap debridement & perforated&Nano, Open flap debridment &Occlusive&Nano |
| Perforated collagen membraneMembrane perforations using dental needle | Other | Open flap debridement & perforated&Nano |
| Occlusive membraneBiotech collagen membrane | Other | Open flap debridment &Occlusive&Nano |
| NanohydroxyapetiteNanbone Particles | Other | Open flap debridement & perforated&Nano, Open flap debridment &Occlusive&Nano |
Primary outcome
CAL
Time frame: Change from base line to 3 months and 6 months
Clinical attachment level
1 secondary outcome
DOD
Time frame: Change from base line to 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 17 Jan 2018.
Related trials for Intrabony Periodontal Defect
Recruiting
Treating Intrabony Defect With MINST VS MINST Extended PRF
Periodontal Intrabony Defects
Recruiting
Treatment of Intrabony Defects With Injectable Platelet-Rich Fibrin and Xenogenic Grafts
Periodontitis, Intrabony Periodontal Defect
Not yet recruiting
Alb-PRF as an Adjunct to Regenerative Periodontal Surgery
Periodontitis, Periodontitis Stage III
Active, not recruiting
C-PRF With Minimally Invasive Non-Surgical Periodontal Therapy
Periodontitis, Intrabony Periodontal Defect
Recruiting
Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
Guided Tissue Regeneration, Periodontal / Methods, Dental Enamel Proteins* / Therapeutic Use
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.
Questions about this trial
What is this clinical trial studying?
A study testing Open flap debridment, Perforated collagen membrane and Occlusive membrane in people with Intrabony Periodontal Defect, run by Ain Shams University.
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 6 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 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
CAL (time frame: Change from base line to 3 months and 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 17 Jan 2018.