Dental ImplantsNCT04683991
Increased Peri-implant Keratinized Mucosal Thickness at Different Operative Times
A study testing Subepithelial connective tissue graft in people with Dental Implants and Peri-Implantitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Keratinized mucosa, which is composed of free gingiva and attached gingiva, is a barrier against bacterial invasion in oral cavity and provides good tissue sealing for periodontal environment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dental Implants, Peri-Implantitis
- What is being tested?
- Subepithelial connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2021to 31 Dec 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No systemic diseases or pregnancy;
- The thickness of keratinized mucosa where the posterior tooth is missing is less than 2 mm;
- Full-mouth plaque score (FMPS) < 20% (measured at four sites per tooth) and bleeding on probing score (BOP%) ≤25% (measured at six sites per tooth);
- Periodontal condition is stable, no probing depths ≥5 mm;
- No previous soft tissue augmentation procedure at experimental site;
- The patient has signed informed consent and accepts the operation of subepithelial connective tissue transplantation.
Who cannot join
- Patients with uncontrolled hypertension;
- Patients with uncontrolled diabetes;
- Patients with insufficient oral hygiene and Untreated periodontitis;
- Pregnant or lactating women;
- Smoker;
- Patients with long-term (> 6 months) use of glucocorticoids;
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- History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years;
- Patients with severe cardiovascular problems;
- Patients with uncontrolled infectious or metabolic diseases;
- Patients with substance abuse.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Oral Medicine, the Second Affiliated Hospital, School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310009
Weilian Sun
About this study
Official title: The Effect of Different Surgical Timing on the Clinical Efficacy of Increasing the Thickness of Keratinized Mucosa Around a Single Posterior Implant: a Prospective, Randomized Controlled Clinical Trial
Keratinized mucosa, which is composed of free gingiva and attached gingiva, is a barrier against bacterial invasion in oral cavity and provides good tissue sealing for periodontal environment. When the keratinized mucosa is insufficient, it is difficult to maintain the long-term stability of the implant, which is not conducive to the peri-implant health. It is generally believed that enough keratinized mucosa width is beneficial to reduce plaque accumulation and reduce the incidence rate of peri-implant diseases. In recent years, clinicians have gradually recognized that the thickness of keratinized mucosa plays an important role in maintaining the peri-implant health. Some researchers found that the thickness of mucosa is very important to maintain the aesthetic effect of implant restoration, and when the thickness of mucosa around the implant is less than 2mm, alveolar bone absorption will occur to maintain a stable biological width. A meta-analysis showed that when the thickness of the keratinized mucosa around the implant was greater than 2mm, the amount of marginal bone loss was significantly reduced (- 0.8mm, P < 0.0001).
It is considered that autogenous soft tissue graft is the most reliable technology to augment keratinized mucosa. Subepithelial connective tissue graft (SCTG) is a mucogingival surgery that transplant autologous free connective tissue under the pedicled semi thick flap to augment keratinized mucosa. It can effectively increase the thickness of soft tissue, cover the exposed implant, and reconstruct the interdental papilla. It is the gold standard for peri-implant soft tissue agumentation. Keratinized mucosal thickening surgery may be done prior to the surgical phase, after the surgical phase, before loading, or even after loading. It is believed that keratinized mucosal thickening at the same time of implantation can effectively reduce the possibility of mucosal recession after implantation, reduce the amount of marginal bone absorption in the process of osseointegration, which is conducive to maintaining the long-term stability of the implant. For the sake of clear clinical vision and convenient operation, clinicians often choose to thicken the keratinized mucosa during the secondary operation, and also obtain good postoperative effect. However, after the completion of the final repair, the keratinized mucosa thickening surgery increases the difficulty of operation and the technical requirements for the operator. In clinical practice, it is rarely selected to perform keratinized mucosal thickening at this time. At present, the effectiveness of timing on the outcome of soft tissue augmentation is still debated, and, most importantly, a direct comparison between simultaneous and staged procedures remains underexplored.
Therefore, this clinical trial is to prospectively compare the clinical efficacy of simultaneous versus delayed timing of soft tissue augmentation by SCTG placement around single implants, by evaluating the peri-implant marginal bone level change and soft tissue change, so as to provide reference for the formulation of clinical treatment plan and the selection of the best operation time.
- Conditions
- Dental Implants, Peri-Implantitis
- Being tested
- Subepithelial connective tissue graft
- Keywords
- keratinized mucosa thickness, dental Implants, subepithelial connective tissue graft, marginal bone level
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subepithelial connective tissue graftProcedure or surgery
A de-epithelialized connective tissue graft is harvested from the homolateral palate and transplanted around the implant.
| Study group | Role | What they receive |
|---|---|---|
| treatment group 1 | Experimental | At the same time of implant implantation, autologous tissue is transplanted into the recipient area by using Subepithelial connective tissue graft. Receives: Procedure: Subepithelial connective tissue graft |
| treatment group 2 | Experimental | During the second stage operation, autologous tissue is transplanted into the recipient area by using Subepithelial connective tissue graft. Receives: Procedure: Subepithelial connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri-implant marginal bone level change
The bone level of the proximal and distal sites of the implant is measured by oral X-ray parallel projection method. Compare the image value with the actual value to calculate the actual bone level.
Measured: 18 months
Secondary outcomes (6)
peri-implant clinical attachment level change
The distance between the reference point of impression edge and the bottom of gingival groove around the implant.
Measured: 18 months
peri-implant keratinized mucosa width
keratinized tissue measured as the distance between muco-gingival junction and the gingival margin.
Measured: 18 months
peri-implant keratinized mucosa thickness
gingival thickness measured 1.5 mm coronal to the MGJ using an injection needle, perpendicular to the tissue surface, with a silicon stop over the gingival surface.
Measured: 18 months
peri-implant gingival index
Periodontal probe was used to measure 6 sites on buccal and lingual side each time to observe gingival color, texture and bleeding, and record the scores.
Measured: 18 months
peri-implant gingival recession
The distance between the implant shoulder and the gingival margin of the temporary or final crown was measured with a periodontal probe (only when the implant shoulder was visible).
Measured: 18 months
visual analogue scale
Visual analogous scale ( VAS) suggested by WHO was used to assess. Analgesia intensity expressed with 0-10, 0 point as without pain completely, 10 points as unbearable pain.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start27 May 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomized controlled clinical trial were used. Random numbers generated by SPSS26.0 will be placed in sequentially coded, sealed, opaque envelopes. Only "1" or "0" will be generated, and the number of "1" or "0" generated by SPSS26.0 is 17. When the qualifications of the subjects were determined by the researchers, the envelopes were opened sequentially and the subjects were assigned to groups. The number "1" represented the treatment group 1 and the number "0" represented the treatment group 2.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weilian Sun, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683991
- Sponsor's protocol ID
- 2020-782
- Status last verified
- Jan 2021
- First submitted
- 22 Dec 2020
- Last updated
- 5 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Surgical Timing on the Clinical Efficacy of Increasing the Thickness of Keratinized Mucosa Around a Single Posterior Implant: a Prospective, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04683991
- Acronym / sponsor ID
- 2020-782
- Conditions
- Dental Implants, Peri-Implantitis
- Keywords
- keratinized mucosa thickness, dental Implants, subepithelial connective tissue graft, marginal bone level
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Dec 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.
Keratinized mucosa, which is composed of free gingiva and attached gingiva, is a barrier against bacterial invasion in oral cavity and provides good tissue sealing for periodontal environment. When the keratinized mucosa is insufficient, it is difficult to maintain the long-term stability of the implant, which is not conducive to the peri-implant health. It is generally believed that enough keratinized mucosa width is beneficial to reduce plaque accumulation and reduce the incidence rate of peri-implant diseases. In recent years, clinicians have gradually recognized that the thickness of keratinized mucosa plays an important role in maintaining the peri-implant health. Some researchers found that the thickness of mucosa is very important to maintain the aesthetic effect of implant restoration, and when the thickness of mucosa around the implant is less than 2mm, alveolar bone absorption will occur to maintain a stable biological width. A meta-analysis showed that when the thickness of the keratinized mucosa around the implant was greater than 2mm, the amount of marginal bone loss was significantly reduced (- 0.8mm, P < 0.0001).
It is considered that autogenous soft tissue graft is the most reliable technology to augment keratinized mucosa. Subepithelial connective tissue graft (SCTG) is a mucogingival surgery that transplant autologous free connective tissue under the pedicled semi thick flap to augment keratinized mucosa. It can effectively increase the thickness of soft tissue, cover the exposed implant, and reconstruct the interdental papilla. It is the gold standard for peri-implant soft tissue agumentation. Keratinized mucosal thickening surgery may be done prior to the surgical phase, after the surgical phase, before loading, or even after loading. It is believed that keratinized mucosal thickening at the same time of implantation can effectively reduce the possibility of mucosal recession after implantation, reduce the amount of marginal bone absorption in the process of osseointegration, which is conducive to maintaining the long-term stability of the implant. For the sake of clear clinical vision and convenient operation, clinicians often choose to thicken the keratinized mucosa during the secondary operation, and also obtain good postoperative effect. However, after the completion of the final repair, the keratinized mucosa thickening surgery increases the difficulty of operation and the technical requirements for the operator. In clinical practice, it is rarely selected to perform keratinized mucosal thickening at this time. At present, the effectiveness of timing on the outcome of soft tissue augmentation is still debated, and, most importantly, a direct comparison between simultaneous and staged procedures remains underexplored.
Therefore, this clinical trial is to prospectively compare the clinical efficacy of simultaneous versus delayed timing of soft tissue augmentation by SCTG placement around single implants, by evaluating the peri-implant marginal bone level change and soft tissue change, so as to provide reference for the formulation of clinical treatment plan and the selection of the best operation time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomized controlled clinical trial were used. Random numbers generated by SPSS26.0 will be placed in sequentially coded, sealed, opaque envelopes. Only "1" or "0" will be generated, and the number of "1" or "0" generated by SPSS26.0 is 17. When the qualifications of the subjects were determined by the researchers, the envelopes were opened sequentially and the subjects were assigned to groups. The number "1" represented the treatment group 1 and the number "0" represented the treatment group 2.
| Arm | Type | Receives |
|---|---|---|
| treatment group 1 | Experimental | Procedure: Subepithelial connective tissue graftAt the same time of implant implantation, autologous tissue is transplanted into the recipient area by using Subepithelial connective tissue graft. |
| treatment group 2 | Experimental | Procedure: Subepithelial connective tissue graftDuring the second stage operation, autologous tissue is transplanted into the recipient area by using Subepithelial connective tissue graft. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- No systemic diseases or pregnancy;
- The thickness of keratinized mucosa where the posterior tooth is missing is less than 2 mm;
- Full-mouth plaque score (FMPS) < 20% (measured at four sites per tooth) and bleeding on probing score (BOP%) ≤25% (measured at six sites per tooth);
- Periodontal condition is stable, no probing depths ≥5 mm;
- No previous soft tissue augmentation procedure at experimental site;
Key exclusion criteria (10 listed)
- Patients with uncontrolled hypertension;
- Patients with uncontrolled diabetes;
- Patients with insufficient oral hygiene and Untreated periodontitis;
- Pregnant or lactating women;
- Smoker;
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 |
|---|---|---|
| Subepithelial connective tissue graftA de-epithelialized connective tissue graft is harvested from the homolateral palate and transplanted around the implant. | Procedure or surgery | treatment group 1, treatment group 2 |
Primary outcome
peri-implant marginal bone level change
Time frame: 18 months
The bone level of the proximal and distal sites of the implant is measured by oral X-ray parallel projection method. Compare the image value with the actual value to calculate the actual bone level.
6 secondary outcomes
peri-implant clinical attachment level change
Time frame: 18 months
peri-implant keratinized mucosa width
Time frame: 18 months
peri-implant keratinized mucosa thickness
Time frame: 18 months
peri-implant gingival index
Time frame: 18 months
peri-implant gingival recession
Time frame: 18 months
visual analogue scale
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: No
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The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
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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.
Weilian Sun principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subepithelial connective tissue graft in people with Dental Implants and Peri-Implantitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 10 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: status not confirmed, as of the sponsor's last update on 5 Jan 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weilian Sun, PhD (13757119563, weiliansun@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peri-implant marginal bone level change (time frame: 18 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 5 Jan 2022.