PeriodontitisNCT07081230
Comparison Between the Efficacy of Albumin Versus Hyaluronic Acid Scaffold in Combination With Concentrated Growth Factors as an Adjunct to Non-surgical Treatment of Periodontitis
A study testing SRP with hyaluronic acid and SRP + Injectable Platelet-Rich Fibrin in people with Periodontitis, run by husain abduljalil alam at 1 site in Egypt.
Trial summary
The primary objective is to clinically evaluate the efficacy of albumin versus hyaluronic acid scaffolds in combination with concentrated growth factors in the non- surgical treatment of stage II/III periodontitis. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- SRP with hyaluronic acid and SRP + Injectable Platelet-Rich Fibrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jul 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
ii) Inclusion Criteria:
- Patients aging from 25-45 years
- Patients with stage II /III periodontitis
- Systemically free iii) Exclusion Criteria:
- Any systemic condition that may impact the study (21)
- Poor oral hygiene
- Pregnant and breastfeeding women
- Smoking patients.
- Patients received periodontal treatment in the last 6 months
- Unable to comply with study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura university Faculty of dentistry
Al Mansurah, Mansoura, 35516
husain a.jalil alam, BDS, +201500838200, hussainalam@std.mans.edu.eg
HUSAIN A.JALIL ALAM, BDS
About this study
Official title: Comparison Between the Efficacy of Albumin Versus Hyaluronic Acid Scaffold in Combination With Concentrated Growth Factors as an Adjunct to Non-surgical Treatment of Periodontitis (Randomized Controlled Clinical Trial)
The primary objective is to clinically evaluate the efficacy of albumin versus hyaluronic acid scaffolds in combination with concentrated growth factors in the non- surgical treatment of stage II/III periodontitis.
The secondary objective is to evaluate the duration and concentration of different growth factors release in the gingival crevicular fluid.
Read the detailed description
III. Treatment Procedures:
Three weeks prior to treatment all patients will receive phase I periodontal therapy in the form of non-surgical mechanical debridement using ultrasonic and hand instruments, oral hygiene instructions will be demonstrated to all patients.
Group I (Test group 1): will receive mechanical debridement and injection of hyaluronic acid mixed with growth factor concentrates in the periodontal pocket, the growth factor concentrates will be prepared by collecting peripheral blood using 9-10 mL tubes without adding any additives, following blood collection, the blood tubes will be placed in a centrifuge for the 8-min ,two to four milliliters of the initial portion of plasma PPP (platelet-poor plasma) is then collected with a syringe and discarded, leaving the other blood portions, the LPCGF (liquid phase concentrated growth factors) from buffy coat is collected then it will be mixed using a female-female connector with hyaluronic acid and injected into the pocket.
Group II (Test group 2) : will receive mechanical debridement and ALB-PRF will be prepared by collecting peripheral blood using 9-10 mL tubes without adding any additives, following blood collection, the blood tubes will be placed in a centrifuge for the 8-min ,Two to four milliliters of the initial portion of plasma (platelet-poor plasma) is then collected with a syringe and placed into a heating device , while the other blood portions (buffy coat, LPCGF, and red blood cells) are placed in a cooling storage bag. The syringes containing PPP are then inserted into a heating device for human serum albumin denaturation plasma to produce the albumin gel. After 10 minutes at an operating temperature of 75°C, the syringes are then removed and allowed to cool in a cooling storage bag and protected from ambient light. The LPCGF (liquid phase concentrated growth factors) from buffy coat are then collected. Thereafter, the albumin gel and the liquid-CGF are mixed between syringes by passing back and forth (roughly 10×) using a female-female connector to create ALB-PRF which is ready to be injected in the periodontal pocket, ALB-PRF gel will be injected into periodontal pocket by special needle until it is full.
Group III (Control group): will receive mechanical debridement only. All patients will be advised not to eat hard food, they were also advised not to brush the area for 12h or to floss or use interproximal cleaning devices for ten days. During the study period, the patients were instructed to continue regular tooth brushing and interdental cleansing, also instructed not to use any mouth washes for the Duration of the study.
- Conditions
- Periodontitis
- Being tested
- SRP with hyaluronic acid, SRP + Injectable Platelet-Rich Fibrin
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRP with hyaluronic acidCombination product
patients will receive hyaluronic acid mixed with concentrated growth factors injected into the periodontal pocket after mechanical debridement
SRP + Injectable Platelet-Rich FibrinCombination product
patients will receive Albumin gel mixed with concentrated growth factors injected into the periodontal pocket after mechanical debridement
| Study group | Role | What they receive |
|---|---|---|
| HYALURONIC ACID MIX WITH CGF | Experimental | patients will receive hyaluronic acid mixed with concentrated growth factors after mechanical debridement Receives: Combination Product: SRP with hyaluronic acid |
| ALB PRF | Experimental | patients will receive Albumin gel mixed with concentrated growth factors after mechanical debridement Receives: Combination Product: SRP + Injectable Platelet-Rich Fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index (PI)
- Plaque index (PI):The index assigns a score to each tooth based on the amount of plaque present.
0: No plaque is visible.
- A thin film of plaque is present at the gingival margin (gumline) and can be detected with a probe.
- Visible plaque along the gingival margin.
- Heavy plaque accumulation in the gingival margin and interdental spaces.
Measured: baseline, 6weeks, 12weeks
Bleeding on probing (BOP)
"0" if no bleeding occurred within 10 second, and "1" if there was bleeding within 10 second.
Measured: baseline, 6weeks, 12weeks
Probing pocket Depth (PPD)
will be measured from the gingival margin to the base of the periodontal pocket
Measured: baseline, 6weeks, 12weeks
Clinical Attachment Level (CAL)
will be measured from the cement-enamel junction to the base of the periodontal pocket
Measured: baseline, 6weeks, 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start7 Jul 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Single group
- Model description
- Patients will be randomly divided into 3 groups with (10) patients each. Group I (Test group 1): patients will receive hyaluronic acid mixed with concentrated growth factors after mechanical debridement. Group II (Test group 2): patients will receive Albumin gel mixed with concentrated growth factors after mechanical debridement. Group III (Control group): patients will receive mechanical debridement only.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- husain abduljalil alam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, husain abduljalil alam, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081230
- Sponsor's protocol ID
- A03010250M
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Efficacy of Albumin Versus Hyaluronic Acid Scaffold in Combination With Concentrated Growth Factors as an Adjunct to Non-surgical Treatment of Periodontitis (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07081230
- Acronym / sponsor ID
- A03010250M
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- husain abduljalil alamUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 23 Jul 2025 (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 primary objective is to clinically evaluate the efficacy of albumin versus hyaluronic acid scaffolds in combination with concentrated growth factors in the non- surgical treatment of stage II/III periodontitis.
The secondary objective is to evaluate the duration and concentration of different growth factors release in the gingival crevicular fluid.
Detailed description
III. Treatment Procedures:
Three weeks prior to treatment all patients will receive phase I periodontal therapy in the form of non-surgical mechanical debridement using ultrasonic and hand instruments, oral hygiene instructions will be demonstrated to all patients.
Group I (Test group 1): will receive mechanical debridement and injection of hyaluronic acid mixed with growth factor concentrates in the periodontal pocket, the growth factor concentrates will be prepared by collecting peripheral blood using 9-10 mL tubes without adding any additives, following blood collection, the blood tubes will be placed in a centrifuge for the 8-min ,two to four milliliters of the initial portion of plasma PPP (platelet-poor plasma) is then collected with a syringe and discarded, leaving the other blood portions, the LPCGF (liquid phase concentrated growth factors) from buffy coat is collected then it will be mixed using a female-female connector with hyaluronic acid and injected into the pocket.
Group II (Test group 2) : will receive mechanical debridement and ALB-PRF will be prepared by collecting peripheral blood using 9-10 mL tubes without adding any additives, following blood collection, the blood tubes will be placed in a centrifuge for the 8-min ,Two to four milliliters of the initial portion of plasma (platelet-poor plasma) is then collected with a syringe and placed into a heating device , while the other blood portions (buffy coat, LPCGF, and red blood cells) are placed in a cooling storage bag. The syringes containing PPP are then inserted into a heating device for human serum albumin denaturation plasma to produce the albumin gel. After 10 minutes at an operating temperature of 75°C, the syringes are then removed and allowed to cool in a cooling storage bag and protected from ambient light. The LPCGF (liquid phase concentrated growth factors) from buffy coat are then collected. Thereafter, the albumin gel and the liquid-CGF are mixed between syringes by passing back and forth (roughly 10×) using a female-female connector to create ALB-PRF which is ready to be injected in the periodontal pocket, ALB-PRF gel will be injected into periodontal pocket by special needle until it is full.
Group III (Control group): will receive mechanical debridement only. All patients will be advised not to eat hard food, they were also advised not to brush the area for 12h or to floss or use interproximal cleaning devices for ten days. During the study period, the patients were instructed to continue regular tooth brushing and interdental cleansing, also instructed not to use any mouth washes for the Duration of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomly divided into 3 groups with (10) patients each. Group I (Test group 1): patients will receive hyaluronic acid mixed with concentrated growth factors after mechanical debridement. Group II (Test group 2): patients will receive Albumin gel mixed with concentrated growth factors after mechanical debridement. Group III (Control group): patients will receive mechanical debridement only.
| Arm | Type | Receives |
|---|---|---|
| HYALURONIC ACID MIX WITH CGF | Experimental | Combination Product: SRP with hyaluronic acidpatients will receive hyaluronic acid mixed with concentrated growth factors after mechanical debridement |
| ALB PRF | Experimental | Combination Product: SRP + Injectable Platelet-Rich Fibrinpatients will receive Albumin gel mixed with concentrated growth factors after mechanical debridement |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| SRP with hyaluronic acidpatients will receive hyaluronic acid mixed with concentrated growth factors injected into the periodontal pocket after mechanical debridement | Combination product | HYALURONIC ACID MIX WITH CGF |
| SRP + Injectable Platelet-Rich Fibrinpatients will receive Albumin gel mixed with concentrated growth factors injected into the periodontal pocket after mechanical debridement | Combination product | ALB PRF |
Primary outcome
Plaque index (PI)
Time frame: baseline, 6weeks, 12weeks
1. Plaque index (PI):The index assigns a score to each tooth based on the amount of plaque present. 0: No plaque is visible. 1. A thin film of plaque is present at the gingival margin (gumline) and can be detected with a probe. 2. Visible plaque along the gingival margin. 3. Heavy plaque accumulation in the gingival margin and interdental spaces.
Bleeding on probing (BOP)
Time frame: baseline, 6weeks, 12weeks
"0" if no bleeding occurred within 10 second, and "1" if there was bleeding within 10 second.
Probing pocket Depth (PPD)
Time frame: baseline, 6weeks, 12weeks
will be measured from the gingival margin to the base of the periodontal pocket
Clinical Attachment Level (CAL)
Time frame: baseline, 6weeks, 12weeks
will be measured from the cement-enamel junction to the base of the periodontal pocket
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRP with hyaluronic acid and SRP + Injectable Platelet-Rich Fibrin in people with Periodontitis, run by husain abduljalil alam 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?
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: looking for participants now, as of the sponsor's last update on 23 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HUSAIN A.JALIL ALAM, BDS (+201500838200, hussainalam@std.mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index (PI) (time frame: baseline, 6weeks, 12weeks). The study lists 4 primary outcomes in all. 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 23 Jul 2025.