Dental Implant, Periotest, CTX,Delayed Loading, ELISA, Early Loading, SalivaNCT06246097
INVESTIGATION of EXPRESSION of CTXI LEVELS IN SALIVA WITH EARLY and DELAYED LOADING of DENTAL IMPLANTS
An observational study of Dental Implant, Periotest, CTX,Delayed Loading, ELISA, Early Loading, Saliva, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Background: Implants are commonly used as a treatment choice for partially dentate or in edentulous patients. Currently, no specific biomarker to assess the bone status around the dental implants of healthy patients has been reported to further evaluate bone deposition, resorption and stability. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Periotest, CTX,Delayed Loading, ELISA, Early Loading, Saliva
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Oct 2021to 18 Nov 2022
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients coming to OPD of Dow International Dental College for implant placement in posterior mandible (molar area) will be recruited in the study.
Who may be able to join
- Healthy subjects of age 18 and above.
- Patients who have consented to be part of the study.
- Patients in whom only posterior mandibular implants are to be placed.
Who cannot join
- • Patients with known bone diseases such as osteoarthritis, osteoporosis etc.
- Patient with uncontrolled diabetes and uncontrolled hypertension etc.
- Patients who need maxillary implants.
- Patients treated with oral cancer.
- Patients who are given implants in fresh extraction sockets.
- Patients in whom bone augmentation is needed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INVESTIGATION of EXPRESSION of C-TERMINAL CROSS-LINKING TELOPEPTIDE of TYPE I COLLAGEN(CTXI) LEVELS IN SALIVA WITH EARLY and DELAYED LOADING of DENTAL IMPLANTS
Background:
Implants are commonly used as a treatment choice for partially dentate or in edentulous patients. Currently, no specific biomarker to assess the bone status around the dental implants of healthy patients has been reported to further evaluate bone deposition, resorption and stability. CTX (C-terminal telopeptide) is a known specific biomarker for bone resorption. CTX levels evaluation in serum and urine of patients with bisphosphonates treatment has already been reported. However, its levels in saliva of healthy patients with dental implants has not been investigated, so far.
Read more
Objectives:
The aim of this study is to evaluate salivary CTX levels in dental implants with early and delayed loading and to compare it with the values of mechanical stability test (Periotest).
Methods:
Patients coming to OPD of Oral Surgery department of Dow International Dental College (DIDC) and are willing for placement of implant in the posterior molar area of mandible will be enrolled in the study. Informed consent will be taken from each patient for participation in the study. Dental implants placement will be performed according to the standard protocols. All patients will be assessed for implant stability on the day of surgery, at 1 month, 2 month and 3 months by Periotest assessment. Also, saliva will be collected and stored from same patients. Later, ELISA will be performed for expressional analysis of CTX.
Read the detailed description
40 Patients coming to OPD of Dow International Dental College for implant placement in posterior mandible (molar area) will be recruited in the study.
Dental implants available in the Outpatient Department (OPD) of Dow International Dental College (DIDC) will be placed in patients. Dental implants will be placed according to the standard protocols by Dr. Shaheen Ahmed.
Patients will be divided in two groups. Group A patients will be early loaded, and group B will be conventional loaded with prosthesis.
Each patient will be evaluated for implant stability after the surgery, at 1 month, 2 months and 3 months with the help of Periotest.
Saliva will be collected from patients in both the groups before placement of implant and on the same days as of Periotest evaluations after surgery. Saliva will be processed and immediately stored at -80oC. Later sandwich ELISA will be performed for expressional analysis of CTX.
Levels of CTX before implant surgery will be served as reference value in this study.
2.9.1 Saliva Collection Method:
Whole unstimulated saliva (WUS) will be collected from both the study groups. The process of saliva collection is as follows:
- Salivary samples will be collected between 9-11 am to minimize diurnal variations in salivary flow and changes in the sialo chemistry.
- Patients will be asked to refrain from smoking, drinking and chewing at least one hour before saliva collection to avoid interference of water and food with the analysis.
- To remove any food debris from mouth, the patients will be asked to wash the mouth with water before saliva collection.
- After rinsing thoroughly, an interval of at least 10 minutes will be given before the collection of saliva samples to avoid sample dilution.
- Patients will be asked to spit the saliva in a sterilized falcon tube of 15mL.
- Approximately 2-5 mL of saliva will be collected from each patient.
- Patient will be informed and told not to cough up mucus.
- After saliva collection, samples will be immediately taken to the laboratory for further processing.
- Salivary samples will be centrifuged at 8000rpm for 15 min at 4˚C to remove any cell debris and supernatant will be collected.
- The collected supernatant will be aliquoted into microtubes of 1ml and will be stored at -80°C until further analysis (processing time of saliva will be kept lowest as possible).
2.9.2 Salivary Analysis:
Enzyme Linked Immunosorbent Assay (Sandwich Technique):
CTX levels in salivary samples of all the groups will be analyzed by sandwich ELISA (Enzyme Linked Immunosorbent Assay) technique. ELISA testing will be performed by using CTX kit according to manufacturer's instruction. The plate pre-coated with antibody specific to Human CTX will be provided with the kit. Standards or samples are added to the micro ELISA plate wells which allows CTX to bind to its specific antibody. After removing unbound sample, biotinylated CTX detection antibody will be added followed by washing with the buffer. After washing, plate will be incubated with Streptavidin-Horseradish Peroxidase (HRP) that will binds to detection antibody. After incubation, unbound Streptavidin-HRP will be washed away. Finally, substrate solution will be added. The intensity of color developed is proportional to the amount of human CTX present in the sample. The reaction will be stopped by the addition of stop solution and absorbance will be measured spectrophotometrically at 450 nm wavelength. The concentration of CTX in samples is obtained by comparing absorbance of samples to the standards.
ELISA will be performed by principal investigator of the study with the help of her Co-supervisor in DRIBBS (Dow Research Institute of Biotechnology and Biomedical Sciences).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | early loading of dental implants within a month | |
| group 2 | delayed loading of dental implants within 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
c terminal telopeptide of type I collagen
bone resorption biomarker
Measured: 3 monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start10 Oct 2021
- Primary completion26 Oct 2022
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dental Implant, Periotest, CTX,Delayed Loading, ELISA, Early Loading, SalivaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dania Hamid, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246097
- Sponsor's protocol ID
- dowuhs123
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elani HW, Starr JR, Da Silva JD, Gallucci GO. Trends in Dental Implant Use in the U.S., 1999-2016, and Projections to 2026. J Dent Res. 2018 Dec;97(13):1424-1430. doi: 10.1177/0022034518792567. Epub 2018 Aug 3.
PubMed 30075090Guglielmotti MB, Olmedo DG, Cabrini RL. Research on implants and osseointegration. Periodontol 2000. 2019 Feb;79(1):178-189. doi: 10.1111/prd.12254.
PubMed 30892769Esposito M, Siormpas K, Mitsias M, Bechara S, Trullenque-Eriksson A, Pistilli R. Immediate, early (6 weeks) and delayed loading (3 months) of single implants: 4-month post-loading from a multicenter pragmatic randomised controlled trial. Eur J Oral Implantol. 2016;9(3):249-260.
PubMed 27722223Zhu Y, Zheng X, Zeng G, Xu Y, Qu X, Zhu M, Lu E. Clinical efficacy of early loading versus conventional loading of dental implants. Sci Rep. 2015 Nov 6;5:15995. doi: 10.1038/srep15995.
PubMed 26542097Le Guehennec L, Soueidan A, Layrolle P, Amouriq Y. Surface treatments of titanium dental implants for rapid osseointegration. Dent Mater. 2007 Jul;23(7):844-54. doi: 10.1016/j.dental.2006.06.025. Epub 2006 Aug 14.
PubMed 16904738Hamid D, Ahmed S, Shaikh AH, Nisar S, Memon R, Malik S. Investigation of the expression of the C-terminal cross-linking telopeptide of type I collagen (CTXI) in saliva during early and delayed loading of dental implants. BMC Oral Health. 2025 Jul 2;25(1):1013. doi: 10.1186/s12903-025-05529-x.
PubMed 40604796
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATION of EXPRESSION of C-TERMINAL CROSS-LINKING TELOPEPTIDE of TYPE I COLLAGEN(CTXI) LEVELS IN SALIVA WITH EARLY and DELAYED LOADING of DENTAL IMPLANTS
- ClinicalTrials.gov ID
- NCT06246097
- Acronym / sponsor ID
- dowuhs123
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 7 Feb 2024 (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.
Background:
Implants are commonly used as a treatment choice for partially dentate or in edentulous patients. Currently, no specific biomarker to assess the bone status around the dental implants of healthy patients has been reported to further evaluate bone deposition, resorption and stability. CTX (C-terminal telopeptide) is a known specific biomarker for bone resorption. CTX levels evaluation in serum and urine of patients with bisphosphonates treatment has already been reported. However, its levels in saliva of healthy patients with dental implants has not been investigated, so far.
Objectives:
The aim of this study is to evaluate salivary CTX levels in dental implants with early and delayed loading and to compare it with the values of mechanical stability test (Periotest).
Methods:
Patients coming to OPD of Oral Surgery department of Dow International Dental College (DIDC) and are willing for placement of implant in the posterior molar area of mandible will be enrolled in the study. Informed consent will be taken from each patient for participation in the study. Dental implants placement will be performed according to the standard protocols. All patients will be assessed for implant stability on the day of surgery, at 1 month, 2 month and 3 months by Periotest assessment. Also, saliva will be collected and stored from same patients. Later, ELISA will be performed for expressional analysis of CTX.
Detailed description
40 Patients coming to OPD of Dow International Dental College for implant placement in posterior mandible (molar area) will be recruited in the study.
Dental implants available in the Outpatient Department (OPD) of Dow International Dental College (DIDC) will be placed in patients. Dental implants will be placed according to the standard protocols by Dr. Shaheen Ahmed.
Patients will be divided in two groups. Group A patients will be early loaded, and group B will be conventional loaded with prosthesis.
Each patient will be evaluated for implant stability after the surgery, at 1 month, 2 months and 3 months with the help of Periotest.
Saliva will be collected from patients in both the groups before placement of implant and on the same days as of Periotest evaluations after surgery. Saliva will be processed and immediately stored at -80oC. Later sandwich ELISA will be performed for expressional analysis of CTX.
Levels of CTX before implant surgery will be served as reference value in this study.
2.9.1 Saliva Collection Method:
Whole unstimulated saliva (WUS) will be collected from both the study groups. The process of saliva collection is as follows:
- Salivary samples will be collected between 9-11 am to minimize diurnal variations in salivary flow and changes in the sialo chemistry.
- Patients will be asked to refrain from smoking, drinking and chewing at least one hour before saliva collection to avoid interference of water and food with the analysis.
- To remove any food debris from mouth, the patients will be asked to wash the mouth with water before saliva collection.
- After rinsing thoroughly, an interval of at least 10 minutes will be given before the collection of saliva samples to avoid sample dilution.
- Patients will be asked to spit the saliva in a sterilized falcon tube of 15mL.
- Approximately 2-5 mL of saliva will be collected from each patient.
- Patient will be informed and told not to cough up mucus.
- After saliva collection, samples will be immediately taken to the laboratory for further processing.
- Salivary samples will be centrifuged at 8000rpm for 15 min at 4˚C to remove any cell debris and supernatant will be collected.
- The collected supernatant will be aliquoted into microtubes of 1ml and will be stored at -80°C until further analysis (processing time of saliva will be kept lowest as possible).
2.9.2 Salivary Analysis:
Enzyme Linked Immunosorbent Assay (Sandwich Technique):
CTX levels in salivary samples of all the groups will be analyzed by sandwich ELISA (Enzyme Linked Immunosorbent Assay) technique. ELISA testing will be performed by using CTX kit according to manufacturer's instruction. The plate pre-coated with antibody specific to Human CTX will be provided with the kit. Standards or samples are added to the micro ELISA plate wells which allows CTX to bind to its specific antibody. After removing unbound sample, biotinylated CTX detection antibody will be added followed by washing with the buffer. After washing, plate will be incubated with Streptavidin-Horseradish Peroxidase (HRP) that will binds to detection antibody. After incubation, unbound Streptavidin-HRP will be washed away. Finally, substrate solution will be added. The intensity of color developed is proportional to the amount of human CTX present in the sample. The reaction will be stopped by the addition of stop solution and absorbance will be measured spectrophotometrically at 450 nm wavelength. The concentration of CTX in samples is obtained by comparing absorbance of samples to the standards.
ELISA will be performed by principal investigator of the study with the help of her Co-supervisor in DRIBBS (Dow Research Institute of Biotechnology and Biomedical Sciences).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –early loading of dental implants within a month |
| group 2 | – | –delayed loading of dental implants within 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients coming to OPD of Dow International Dental College for implant placement in posterior mandible (molar area) will be recruited in the study.
Key inclusion criteria (3 listed)
- Healthy subjects of age 18 and above.
- Patients who have consented to be part of the study.
- Patients in whom only posterior mandibular implants are to be placed.
Key exclusion criteria (6 listed)
- • Patients with known bone diseases such as osteoarthritis, osteoporosis etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
c terminal telopeptide of type I collagen
Time frame: 3 monts
bone resorption biomarker
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 7 Feb 2024.
- Background: PubMed 30075090Elani HW, Starr JR, Da Silva JD, Gallucci GO. Trends in Dental Implant Use in the U.S., 1999-2016, and Projections to 2026. J Dent Res. 2018 Dec;97(13):1424-1430. doi: 10.1177/0022034518792567. Epub 2018 Aug 3.
- Background: PubMed 30892769Guglielmotti MB, Olmedo DG, Cabrini RL. Research on implants and osseointegration. Periodontol 2000. 2019 Feb;79(1):178-189. doi: 10.1111/prd.12254.
- Background: PubMed 27722223Esposito M, Siormpas K, Mitsias M, Bechara S, Trullenque-Eriksson A, Pistilli R. Immediate, early (6 weeks) and delayed loading (3 months) of single implants: 4-month post-loading from a multicenter pragmatic randomised controlled trial. Eur J Oral Implantol. 2016;9(3):249-260.
- Background: PubMed 26542097Zhu Y, Zheng X, Zeng G, Xu Y, Qu X, Zhu M, Lu E. Clinical efficacy of early loading versus conventional loading of dental implants. Sci Rep. 2015 Nov 6;5:15995. doi: 10.1038/srep15995.
- Background: PubMed 16904738Le Guehennec L, Soueidan A, Layrolle P, Amouriq Y. Surface treatments of titanium dental implants for rapid osseointegration. Dent Mater. 2007 Jul;23(7):844-54. doi: 10.1016/j.dental.2006.06.025. Epub 2006 Aug 14.
- Derived from this study: PubMed 40604796Hamid D, Ahmed S, Shaikh AH, Nisar S, Memon R, Malik S. Investigation of the expression of the C-terminal cross-linking telopeptide of type I collagen (CTXI) in saliva during early and delayed loading of dental implants. BMC Oral Health. 2025 Jul 2;25(1):1013. doi: 10.1186/s12903-025-05529-x.
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?
An observational study of Dental Implant, Periotest, CTX,Delayed Loading, ELISA, Early Loading, Saliva, run by Dow University of Health Sciences at 1 site in Pakistan.
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 3 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 7 Feb 2024. 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 Pakistan. 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?
c terminal telopeptide of type I collagen (time frame: 3 monts). 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 NCT06246097, which also lists 6 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 7 Feb 2024.