Crown LengtheningNCT03947658
Influence of Restorative Timing on Crown Lengthening Outcome.
A study testing Surgical crown lengthening in people with Crown Lengthening, run by Aristotle University Of Thessaloniki.
Trial summary
Setting the restorative margins for teeth with short clinical crowns is challenging and crown lengthening surgery (CLS) is often necessary. The aim of this study was to assess the influence of prosthetic restorative treatment timing on gingival margin location of teeth after crown lengthening surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crown Lengthening
- What is being tested?
- Surgical crown lengthening
- 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
- Jan 2017to Jan 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 18 years,
- periodontally healthy or periodontally treated subjects with Plaque scores ≤15% \& GI ≤15%
- each patient could participate with one tooth only,
- non-smokers or smokers of less than 5 cigarettes per day,
- target tooth should be surrounded by both the adjacent teeth which should not be restored,
- provisional and final prosthetic margins should not extend subgingivally,
Show all 9Show fewer
- in case of fracture this should be radiographically detectable,
- if a root canal treatment was necessary it should have been completed at least 6 months earlier.
- both anterior and posterior teeth included.
Who cannot join
- the presence of syndromes affecting bone metabolism,
- any kind of contraindication for periodontal surgery,
- pregnancy or lactation,
- no compliance with re-examinations or oral hygiene performance
- cases where gingivectomy or apically repositioned flap without osseous resection were indicated
About this study
Official title: Influence of Prosthetic Restorative Treatment Timing on Gingival Margin of Teeth After Surgical Crown Lengthening: a Randomized Controlled Pilot Study.
Setting the restorative margins for teeth with short clinical crowns is challenging and crown lengthening surgery (CLS) is often necessary. The aim of this study was to assess the influence of prosthetic restorative treatment timing on gingival margin location of teeth after crown lengthening surgery.
Eighteen patients requiring CLS were enrolled in the study and divided into two groups depending on the timing of prosthetic rehabilitation, at 6 or fourteen weeks after CLS.Clinical parameters were recorded around treated and neighboring teeth with adjacent and non-adjacent sites at 6 and 14 weeks after surgery as well as three and six months after prosthesis delivery. Alveolar ridge changes were assessed via digital X-rays.Soft tissue healing and the final treatment outcome were assessed by both patients and prosthodontists.
Read the detailed description
Twenty patients selected from those referred to the Department of Periodontics for crown lengthening surgery were enrolled in the study (9 females, 11 males, 19-65 years old, mean age:45.2) Patients were randomly assigned to one of the two experimental groups. For the first group of patients (A), prosthetic restoration started 6 weeks whereas for the second group (B)14 weeks after surgery. After recording of pre-surgical measurements, intrasulcular or internal bevel incisions were performed buccally and lingually, and full-thickness mucoperiosteal flaps were raised. Buccal flaps were reflected to a level beyond the mucogingival junction. The osseous crest and subgingival tooth structure were exposed. The osseous resection was performed after considering the amount of additional tooth structure required for restorative purpose and the preoperative Supracrestal Tissue Attachment at each site with hand and rotary instruments in a manner of establishing positive bone architecture. After root planing, suturing of the surgical sites was performed. The flap margins were placed at or apical to the anticipated crown margin after suturing and as far from the osseous crest as possible and necessary postoperative instructions were given. Patients were recalled 1 week post-surgery for suture removal, oral hygiene reinforcement and healing assessment. Healing was also evaluated at the end of the second post-operative week. All patients were reevaluated at 3 and 6 months after the prosthesis delivery.
- Conditions
- Crown Lengthening
- Being tested
- Surgical crown lengthening
- Keywords
- surgical, prosthetic restoration, gingiva, surgical flaps, stents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical crown lengtheningProcedure or surgery
Surgical lengthening of teeth with short clinical crown and prosthetic rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Six weeks group | Experimental | Prosthetic restoration started 6 weeks after surgical crown lengthening Receives: Procedure: Surgical crown lengthening |
| Fourteen weeks group | Experimental | Prosthetic restoration started 14 weeks after surgical crown lengthening Receives: Procedure: Surgical crown lengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative gingival margin location change
The relative position of free gingival margin as measured from an individualized reference stent in millimeters
Measured: 6 months after prosthesis delivery (30 to 38 weeks after surgery)
Secondary outcomes (4)
Pocket depth
Distance from gingival margin-the base of the pocket in millimeters
Measured: before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery,at prosthesis delivery, 3 and 6 months after prosthesis delivery
Relative clinical attachment loss
Distance from reference stent to the base of the pocket in millimeters
Measured: before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery
Plaque index
The number of sites presenting with dental plaque appositions
Measured: before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery
Gingival bleeding index
The number of sites presenting with bleeding on probing
Measured: before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study startJan 2017
- Primary completionJun 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crown LengtheningStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsachouridou Ioanna, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947658
- Sponsor's protocol ID
- 30/03-05-2017
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 13 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Malamoudi GA, Tsachouridou I, Menexes G, Mikrogeorgis G, Tortopidis D, Tsalikis L. Pre-restorative crown lengthening surgery: influence of restorative treatment timing on clinical outcomes-a pilot study. Oral Maxillofac Surg. 2024 Mar;28(1):253-267. doi: 10.1007/s10006-023-01138-6. Epub 2023 Jan 25.
PubMed 36695965
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Prosthetic Restorative Treatment Timing on Gingival Margin of Teeth After Surgical Crown Lengthening: a Randomized Controlled Pilot Study.
- ClinicalTrials.gov ID
- NCT03947658
- Acronym / sponsor ID
- 30/03-05-2017
- Conditions
- Crown Lengthening
- Keywords
- surgical, prosthetic restoration, gingiva, surgical flaps, stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 13 May 2019 (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.
Setting the restorative margins for teeth with short clinical crowns is challenging and crown lengthening surgery (CLS) is often necessary. The aim of this study was to assess the influence of prosthetic restorative treatment timing on gingival margin location of teeth after crown lengthening surgery.
Eighteen patients requiring CLS were enrolled in the study and divided into two groups depending on the timing of prosthetic rehabilitation, at 6 or fourteen weeks after CLS.Clinical parameters were recorded around treated and neighboring teeth with adjacent and non-adjacent sites at 6 and 14 weeks after surgery as well as three and six months after prosthesis delivery. Alveolar ridge changes were assessed via digital X-rays.Soft tissue healing and the final treatment outcome were assessed by both patients and prosthodontists.
Detailed description
Twenty patients selected from those referred to the Department of Periodontics for crown lengthening surgery were enrolled in the study (9 females, 11 males, 19-65 years old, mean age:45.2) Patients were randomly assigned to one of the two experimental groups. For the first group of patients (A), prosthetic restoration started 6 weeks whereas for the second group (B)14 weeks after surgery. After recording of pre-surgical measurements, intrasulcular or internal bevel incisions were performed buccally and lingually, and full-thickness mucoperiosteal flaps were raised. Buccal flaps were reflected to a level beyond the mucogingival junction. The osseous crest and subgingival tooth structure were exposed. The osseous resection was performed after considering the amount of additional tooth structure required for restorative purpose and the preoperative Supracrestal Tissue Attachment at each site with hand and rotary instruments in a manner of establishing positive bone architecture. After root planing, suturing of the surgical sites was performed. The flap margins were placed at or apical to the anticipated crown margin after suturing and as far from the osseous crest as possible and necessary postoperative instructions were given. Patients were recalled 1 week post-surgery for suture removal, oral hygiene reinforcement and healing assessment. Healing was also evaluated at the end of the second post-operative week. All patients were reevaluated at 3 and 6 months after the prosthesis delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Six weeks group | Experimental | Procedure: Surgical crown lengtheningProsthetic restoration started 6 weeks after surgical crown lengthening |
| Fourteen weeks group | Experimental | Procedure: Surgical crown lengtheningProsthetic restoration started 14 weeks after surgical crown lengthening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age ≥ 18 years,
- periodontally healthy or periodontally treated subjects with Plaque scores ≤15% \& GI ≤15%
- each patient could participate with one tooth only,
- non-smokers or smokers of less than 5 cigarettes per day,
- target tooth should be surrounded by both the adjacent teeth which should not be restored,
Key exclusion criteria (5 listed)
- the presence of syndromes affecting bone metabolism,
- any kind of contraindication for periodontal surgery,
- pregnancy or lactation,
- no compliance with re-examinations or oral hygiene performance
- cases where gingivectomy or apically repositioned flap without osseous resection were indicated
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 |
|---|---|---|
| Surgical crown lengtheningSurgical lengthening of teeth with short clinical crown and prosthetic rehabilitation | Procedure or surgery | Fourteen weeks group, Six weeks group |
Primary outcome
Relative gingival margin location change
Time frame: 6 months after prosthesis delivery (30 to 38 weeks after surgery)
The relative position of free gingival margin as measured from an individualized reference stent in millimeters
4 secondary outcomes
Pocket depth
Time frame: before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery,at prosthesis delivery, 3 and 6 months after prosthesis delivery
Relative clinical attachment loss
Time frame: before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery
Plaque index
Time frame: before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery
Gingival bleeding index
Time frame: before surgery, immediately after surgery, 6 weeks after surgery, 14 weeks after surgery, at prosthesis delivery, 3 and 6 months after prosthesis delivery
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 13 May 2019.
- Derived from this study: PubMed 36695965Malamoudi GA, Tsachouridou I, Menexes G, Mikrogeorgis G, Tortopidis D, Tsalikis L. Pre-restorative crown lengthening surgery: influence of restorative treatment timing on clinical outcomes-a pilot study. Oral Maxillofac Surg. 2024 Mar;28(1):253-267. doi: 10.1007/s10006-023-01138-6. Epub 2023 Jan 25.
Related trials for Crown Lengthening
Not yet recruiting
Accuracy of Stackable Double Periodontal Guide in Esthetic Crown Lengthening
Gummy Smile of Altered Passive Eruption Type 1B
Recruiting
Periodontal Tissue Stability After Surgical Correction of Altered Passive Eruption
Altered Passive Eruption
Recruiting
Comparison of Er:YAG Assisted Laser Crown Lengthening Against Surgical Crown Lengthening
Crown Lengthening, Crown Lengthening Procedure With Ostectomy
Enrolling by invitation
Laser-Assisted Minimally Invasive Esthetic Crown Lengthening Using Flapless vs. Tunneled Flap Approach
Altered Passive Eruption of Teeth
Not yet recruiting
The Effect of Functional Crown Lengthening Versus Deep Margin Elevation on Periodontal Tissues
TNF Alpha
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 Surgical crown lengthening in people with Crown Lengthening, run by Aristotle University Of Thessaloniki.
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 9 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 13 May 2019. 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?
Relative gingival margin location change (time frame: 6 months after prosthesis delivery (30 to 38 weeks after surgery)). 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 NCT03947658, which also lists 1 linked publication.
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 13 May 2019.