Influence of Restorative Timing on Crown Lengthening Outcome.

NCT ID: NCT03947658

Last Updated: 2019-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Crown Lengthening

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Six weeks group

Prosthetic restoration started 6 weeks after surgical crown lengthening

Group Type EXPERIMENTAL

Surgical crown lengthening

Intervention Type PROCEDURE

Surgical lengthening of teeth with short clinical crown and prosthetic rehabilitation

Fourteen weeks group

Prosthetic restoration started 14 weeks after surgical crown lengthening

Group Type EXPERIMENTAL

Surgical crown lengthening

Intervention Type PROCEDURE

Surgical lengthening of teeth with short clinical crown and prosthetic rehabilitation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgical crown lengthening

Surgical lengthening of teeth with short clinical crown and prosthetic rehabilitation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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,
* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tsachouridou Ioanna

DDS, MSc in Periodontology and Implant Biology, Private practice, Thessaloniki, Greece

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36695965 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

30/03-05-2017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.