Furcation DefectsNCT04443972
Evaluation of Injectable Beta-tricalcium Phosphate Clinically in Treatment of Grade II Furcation Involvement
A study testing PD VitalOs cement®, Hydroxyapatite bone graft and biodegardable collagen membrane in people with Furcation Defects, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
This study will be conducted to evaluate clinically and radiographically the use of PD VitalOs cement® bone graft in the treatment of class II furcation defects comparing with Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Furcation Defects
- What is being tested?
- PD VitalOs cement®, Hydroxyapatite bone graft and biodegardable collagen membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2018to 4 Feb 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Presence of a lower molar with critical size grade II furcation defect (15) with a horizontal component of 4 mm and a vertical component of 4 to 6 mm (18), detected using Naber's probe and William's periodontal probe.
- Patient's age between 30 - 50 years.
- Both sexes.
- The patient should be psychologically accepting the procedures.
- Patients should be systemically free.
Who cannot join
- • Uncooperative patients regarding oral hygiene measures performance.
- Patients with para functional habits.
- Smokers.
- Pregnant or lactating women.
- Patients who underwent any periodontal surgeries in the study site during the six months prior to study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
outpatient clinic of oral medicine department, faculty of dentistry, Alexandria university
Alexandria
About this study
Official title: Evaluation of Injectable Beta- Tricalcium Phosphate as an Occlusive Barrier Membrane in Treatment of Grade ii Furcation Involvement (Clinical and Radiographic Study)
This study will be conducted to evaluate clinically and radiographically the use of PD VitalOs cement® bone graft in the treatment of class II furcation defects comparing with Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.
Read the detailed description
The study is a randomized, controlled clinical trial. Patients were randomly divided into two equal groups, Group I (Test group): included seven Grade II furcation defects treated by beta tricalcium phosphate bone cement only.
Group II (Control group): included seven Grade II furcation defects treated with granulated beta tricalcium phosphate bone graft covered by resorbable collagen membrane.
- Conditions
- Furcation Defects
- Being tested
- PD VitalOs cement®, Hydroxyapatite bone graft, biodegardable collagen membrane
- Keywords
- Grade II Furcation defects
- Medical subject headings
- Furcation Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD VitalOs cement®Other
PD VitalOs cement®* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery
Hydroxyapatite bone graftOther
a bioceramic bone substitute, providing a scaffold for bone deposition
biodegardable collagen membraneOther
provide efficacious barriers that were interposed between the flap and root surface.
| Study group | Role | What they receive |
|---|---|---|
| PD VitalOs cement® alone | Experimental | class II furcation defects that will be treated with PD VitalOs cement® alone Receives: Other: PD VitalOs cement® |
| PD VitalOs cement® plus Bone graft and membrane | Experimental | PD VitalOs cement® and Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects. Receives: Other: PD VitalOs cement®; Other: Hydroxyapatite bone graft; Other: biodegardable collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in plaque index scores (PI) according to Silness and Löe.
Score 0 = no plaque in gingival area. Score 1= film of plaque adhering to the free gingival margin and the adjacent area of the tooth, plaque may only be recognized by running a probe across the tooth surface.
Score 2= moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/ or adjacent tooth surface which can be seen by the naked eye.
Score 3= abundant of soft matter within gingival pocket and/ or the gingival margin and adjacent tooth surface.
The scores from the four surfaces of the tooth were added and divided by (four) to give plaque index for each tooth; the plaque index score for an individual was obtained by adding the indices of the teeth and dividing by the number of the teeth examined.
Measured: at 3 weeks and 6 weeks
change in probing Pocket Depth(PPD)
The measurements were carried out to the defects selected using an 0.8 mm thick periodontal probe * with William's calibration, which was marked from (1-10) mm, pocket depth of (1 mm) or less was recorded as (1mm),measurements exceeding (1mm) but less than (2mm) were recorded as (2mm) so that the probing pocket depth was measured to the nearest mm.
Probing pocket depth refers to the distance from the gingival margin to the bottom of the pocket. Mesial and distal pockets were measured as well as the furcation from the buccal aspect as close as possible to the contact points, facial and lingual pockets were measured at midline of roots.
Efforts were made to insert the probe parallel to the long axis of the roots. Light force was used during the introduction of the probe to the bottom of the pocket, third molars and teeth with enamel projections were excluded. (7)
Measured: at 3 weeks and 6 weeks
change in clinical Attachment Level
The measurements were carried out to the defects selected using an 0.8 mm thick periodontal probe * with William's calibration, which was marked from (1-10) mm, pocket depth of (1 mm) or less was recorded as (1mm),measurements exceeding (1mm) but less than (2mm) were recorded as (2mm) so that the probing pocket depth was measured to the nearest mm.
Probing pocket depth refers to the distance from the gingival margin to the bottom of the pocket. Mesial and distal pockets were measured as well as the furcation from the buccal aspect as close as possible to the contact points, facial and lingual pockets were measured at midline of roots.
Efforts were made to insert the probe parallel to the long axis of the roots. Light force was used during the introduction of the probe to the bottom of the pocket, third molars and teeth with enamel projections were excluded. (7)
Measured: at 3 weeks and 6 weeks
Secondary outcomes (2)
change in radiographic bone level (RBL)
Measured: at basline, 3 and 6 months
change in optical density(OD)
Measured: at basline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start12 Apr 2018
- Primary completion10 Jul 2019
- Study completion4 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Furcation DefectsStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
- Investigators
- Ahmed Hosny Elsayed, BDS, Principal investigator, Alexandria Universityshahira Ali El Damaty, PHD, Study director, Alexandria UniversityGehan Sherif Kotry, PHD, Study director, Alexandria UniversityRania Abd El Aziz Fahmy, PHD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443972
- Sponsor's protocol ID
- Furcation invlvement
- Status last verified
- Jun 2020
- First submitted
- 20 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cutando A, Galindo P, Gomez-Moreno G, Arana C, Bolanos J, Acuna-Castroviejo D, Wang HL. Relationship between salivary melatonin and severity of periodontal disease. J Periodontol. 2006 Sep;77(9):1533-8. doi: 10.1902/jop.2006.050287.
PubMed 16945031Bowers GM, Schallhorn RG, McClain PK, Morrison GM, Morgan R, Reynolds MA. Factors influencing the outcome of regenerative therapy in mandibular Class II furcations: Part I. J Periodontol. 2003 Sep;74(9):1255-68. doi: 10.1902/jop.2003.74.9.1255.
PubMed 14584858Laurell L, Gottlow J, Zybutz M, Persson R. Treatment of intrabony defects by different surgical procedures. A literature review. J Periodontol. 1998 Mar;69(3):303-13. doi: 10.1902/jop.1998.69.3.303.
PubMed 9579616Nasr HF, Aichelmann-Reidy ME, Yukna RA. Bone and bone substitutes. Periodontol 2000. 1999 Feb;19:74-86. doi: 10.1111/j.1600-0757.1999.tb00148.x.
PubMed 10321217Caton JG. Overview of clinical trials on periodontal regeneration. Ann Periodontol. 1997 Mar;2(1):215-22. doi: 10.1902/annals.1997.2.1.215.
PubMed 9151555Mendieta C, Williams RC. Periodontal regeneration with bioresorbable membranes. Curr Opin Periodontol. 1994:157-67.
PubMed 8032456Gray JL, Hancock EB. Guided tissue regeneration. Nonabsorbable barriers. Dent Clin North Am. 1998 Jul;42(3):523-41.
PubMed 9700453Baum BJ, Mooney DJ. The impact of tissue engineering on dentistry. J Am Dent Assoc. 2000 Mar;131(3):309-18. doi: 10.14219/jada.archive.2000.0174.
PubMed 10715922Cury PR, Sallum EA, Nociti FH Jr, Sallum AW, Jeffcoatt MK. Long-term results of guided tissue regeneration therapy in the treatment of class II furcation defects: a randomized clinical trial. J Periodontol. 2003 Jan;74(1):3-9. doi: 10.1902/jop.2003.74.1.3.
PubMed 12593590Basten CH, Ammons WF Jr, Persson R. Long-term evaluation of root-resected molars: a retrospective study. Int J Periodontics Restorative Dent. 1996 Jun;16(3):206-19.
PubMed 9084307Hamp SE, Nyman S, Lindhe J. Periodontal treatment of multirooted teeth. Results after 5 years. J Clin Periodontol. 1975 Aug;2(3):126-35. doi: 10.1111/j.1600-051x.1975.tb01734.x.
PubMed 1058213Hirschfeld L, Wasserman B. A long-term survey of tooth loss in 600 treated periodontal patients. J Periodontol. 1978 May;49(5):225-37. doi: 10.1902/jop.1978.49.5.225.
PubMed 277674Kenney EB, Lekovic V, Elbaz JJ, Kovacvic K, Carranza FA Jr, Takei HH. The use of a porous hydroxylapatite implant in periodontal defects. II. Treatment of Class II furcation lesions in lower molars. J Periodontol. 1988 Feb;59(2):67-72. doi: 10.1902/jop.1988.59.2.67.
PubMed 2831333Eickholz P, Hausmann E. Evidence for healing of Class II and Class III furcations 24 months after guided tissue regeneration therapy: digital subtraction and clinical measurements. J Periodontol. 1999 Dec;70(12):1490-500. doi: 10.1902/jop.1999.70.12.1490.
PubMed 10632525De Leonardis D, Garg AK, Pedrazzoli V, Pecora GE. Clinical evaluation of the treatment of class II furcation involvements with bioabsorbable barriers alone or associated with demineralized freeze-dried bone allografts. J Periodontol. 1999 Jan;70(1):8-12. doi: 10.1902/jop.1999.70.1.8.
PubMed 10052766
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Injectable Beta- Tricalcium Phosphate as an Occlusive Barrier Membrane in Treatment of Grade ii Furcation Involvement (Clinical and Radiographic Study)
- ClinicalTrials.gov ID
- NCT04443972
- Acronym / sponsor ID
- Furcation invlvement
- Conditions
- Furcation Defects
- Keywords
- Grade II Furcation defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 23 Jun 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 study will be conducted to evaluate clinically and radiographically the use of PD VitalOs cement® bone graft in the treatment of class II furcation defects comparing with Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects.
Detailed description
The study is a randomized, controlled clinical trial. Patients were randomly divided into two equal groups, Group I (Test group): included seven Grade II furcation defects treated by beta tricalcium phosphate bone cement only.
Group II (Control group): included seven Grade II furcation defects treated with granulated beta tricalcium phosphate bone graft covered by resorbable collagen membrane.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD VitalOs cement® alone | Experimental | Other: PD VitalOs cement®class II furcation defects that will be treated with PD VitalOs cement® alone |
| PD VitalOs cement® plus Bone graft and membrane | Experimental | Other: PD VitalOs cement®, Other: Hydroxyapatite bone graft, Other: biodegardable collagen membranePD VitalOs cement® and Hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class II furcation defects. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Presence of a lower molar with critical size grade II furcation defect (15) with a horizontal component of 4 mm and a vertical component of 4 to 6 mm (18), detected using Naber's probe and William's periodontal probe.
Key exclusion criteria (5 listed)
- • Uncooperative patients regarding oral hygiene measures performance.
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 |
|---|---|---|
| PD VitalOs cement®PD VitalOs cement®* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery | Other | PD VitalOs cement® alone, PD VitalOs cement® plus Bone graft and membrane |
| Hydroxyapatite bone grafta bioceramic bone substitute, providing a scaffold for bone deposition | Other | PD VitalOs cement® plus Bone graft and membrane |
| biodegardable collagen membraneprovide efficacious barriers that were interposed between the flap and root surface. | Other | PD VitalOs cement® plus Bone graft and membrane |
Primary outcome
change in plaque index scores (PI) according to Silness and Löe.
Time frame: at 3 weeks and 6 weeks
Score 0 = no plaque in gingival area. Score 1= film of plaque adhering to the free gingival margin and the adjacent area of the tooth, plaque may only be recognized by running a probe across the tooth surface. Score 2= moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/ or adjacent tooth surface which can be seen by the naked eye. Score 3= abundant of soft matter within gingival pocket and/ or the gingival margin and adjacent tooth surface. The scores from the four surfaces of the tooth were added and divided by (four) to give plaque index for each tooth; the plaque index score for an individual was obtained by adding the indices of the teeth and dividing by the number of the teeth examined.
change in probing Pocket Depth(PPD)
Time frame: at 3 weeks and 6 weeks
The measurements were carried out to the defects selected using an 0.8 mm thick periodontal probe * with William's calibration, which was marked from (1-10) mm, pocket depth of (1 mm) or less was recorded as (1mm),measurements exceeding (1mm) but less than (2mm) were recorded as (2mm) so that the probing pocket depth was measured to the nearest mm. Probing pocket depth refers to the distance from the gingival margin to the bottom of the pocket. Mesial and distal pockets were measured as well as the furcation from the buccal aspect as close as possible to the contact points, facial and lingual pockets were measured at midline of roots. Efforts were made to insert the probe parallel to the long axis of the roots. Light force was used during the introduction of the probe to the bottom of the pocket, third molars and teeth with enamel projections were excluded. (7)
change in clinical Attachment Level
Time frame: at 3 weeks and 6 weeks
The measurements were carried out to the defects selected using an 0.8 mm thick periodontal probe * with William's calibration, which was marked from (1-10) mm, pocket depth of (1 mm) or less was recorded as (1mm),measurements exceeding (1mm) but less than (2mm) were recorded as (2mm) so that the probing pocket depth was measured to the nearest mm. Probing pocket depth refers to the distance from the gingival margin to the bottom of the pocket. Mesial and distal pockets were measured as well as the furcation from the buccal aspect as close as possible to the contact points, facial and lingual pockets were measured at midline of roots. Efforts were made to insert the probe parallel to the long axis of the roots. Light force was used during the introduction of the probe to the bottom of the pocket, third molars and teeth with enamel projections were excluded. (7)
2 secondary outcomes
change in radiographic bone level (RBL)
Time frame: at basline, 3 and 6 months
change in optical density(OD)
Time frame: at basline, 3 and 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 23 Jun 2020.
- Background: PubMed 16945031Cutando A, Galindo P, Gomez-Moreno G, Arana C, Bolanos J, Acuna-Castroviejo D, Wang HL. Relationship between salivary melatonin and severity of periodontal disease. J Periodontol. 2006 Sep;77(9):1533-8. doi: 10.1902/jop.2006.050287.
- Background: PubMed 14584858Bowers GM, Schallhorn RG, McClain PK, Morrison GM, Morgan R, Reynolds MA. Factors influencing the outcome of regenerative therapy in mandibular Class II furcations: Part I. J Periodontol. 2003 Sep;74(9):1255-68. doi: 10.1902/jop.2003.74.9.1255.
- Background: PubMed 9579616Laurell L, Gottlow J, Zybutz M, Persson R. Treatment of intrabony defects by different surgical procedures. A literature review. J Periodontol. 1998 Mar;69(3):303-13. doi: 10.1902/jop.1998.69.3.303.
- Background: PubMed 10321217Nasr HF, Aichelmann-Reidy ME, Yukna RA. Bone and bone substitutes. Periodontol 2000. 1999 Feb;19:74-86. doi: 10.1111/j.1600-0757.1999.tb00148.x.
- Background: PubMed 9151555Caton JG. Overview of clinical trials on periodontal regeneration. Ann Periodontol. 1997 Mar;2(1):215-22. doi: 10.1902/annals.1997.2.1.215.
- Background: PubMed 8032456Mendieta C, Williams RC. Periodontal regeneration with bioresorbable membranes. Curr Opin Periodontol. 1994:157-67.
- Background: PubMed 9700453Gray JL, Hancock EB. Guided tissue regeneration. Nonabsorbable barriers. Dent Clin North Am. 1998 Jul;42(3):523-41.
- Background: PubMed 10715922Baum BJ, Mooney DJ. The impact of tissue engineering on dentistry. J Am Dent Assoc. 2000 Mar;131(3):309-18. doi: 10.14219/jada.archive.2000.0174.
- Background: PubMed 12593590Cury PR, Sallum EA, Nociti FH Jr, Sallum AW, Jeffcoatt MK. Long-term results of guided tissue regeneration therapy in the treatment of class II furcation defects: a randomized clinical trial. J Periodontol. 2003 Jan;74(1):3-9. doi: 10.1902/jop.2003.74.1.3.
- Background: PubMed 9084307Basten CH, Ammons WF Jr, Persson R. Long-term evaluation of root-resected molars: a retrospective study. Int J Periodontics Restorative Dent. 1996 Jun;16(3):206-19.
- Background: PubMed 1058213Hamp SE, Nyman S, Lindhe J. Periodontal treatment of multirooted teeth. Results after 5 years. J Clin Periodontol. 1975 Aug;2(3):126-35. doi: 10.1111/j.1600-051x.1975.tb01734.x.
- Background: PubMed 277674Hirschfeld L, Wasserman B. A long-term survey of tooth loss in 600 treated periodontal patients. J Periodontol. 1978 May;49(5):225-37. doi: 10.1902/jop.1978.49.5.225.
- Individual participant dataSharing planned: No
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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.
Ahmed Hosny Elsayed, BDS principal investigator
Alexandria University
shahira Ali El Damaty, PHD study director
Alexandria University
Gehan Sherif Kotry, PHD study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PD VitalOs cement®, Hydroxyapatite bone graft and biodegardable collagen membrane in people with Furcation Defects, run by Hams Hamed Abdelrahman 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 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 23 Jun 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. 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?
change in plaque index scores (PI) according to Silness and Löe. (time frame: at 3 weeks and 6 weeks). 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 NCT04443972, which also lists 28 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 23 Jun 2020.